Recommendations for Cleaning and Inspection of Reusable Medical Devices

CONTENTS

Introduction

3

Warnings

3

Limitations on reprocessing

3

Processing Instructions

4

Point of Use

5

Containment and transportation

5

Preparation for Cleaning

5

Cleaning

6

Maintenance, inspection and function testing

7

• Drilling Instruments

17760 - Cannulated Handle-Rasp D12/10

9

• Cannulated Instruments 11145 - Ruland Pilot Wire Guide diameter 2mm length 115mm

10

• Complex Instruments

166978 - Extraction Pliers

11

• Nail Handle

177100, 177120 - Proximal Targeting Arm, Distal Targeting Arm

12

• Probe

OHP2061 - 6mm Piercer Probe - 180mm

14

• Instruments with a graduated scale

177300 - Long Depth Gauge

15

• General Instruments

183336 - M7 Conical Mallet Adaptor

16

• Wrench

17963 - Cephalic Screwdriver II

17

Packaging

18

Sterilization

19

Storage

19

Disclaimer

19

Notice about serious incidents

19

Appendix I

20

• Drilling Instruments

20

• Cannulated Instruments

21

• Complex Instruments

23

• Nail Handle

23

• Probe

24

• Instruments with a graduated scale

24

• General Instruments

24

• Wrench

26

Interpretation of symbols

27

Introduction - Warnings and Limitations on reprocessing

Introduction This document gives general guidance on how reusable medical devices supplied by Orthofix Srl may be reprocessed to prepare them for use. It also explains how to inspect an instrument to determine if it has reached the end of its serviceable life, must not be used, and must be replaced.

• • •

The efficacy of the reprocessing also depends on the equipment, operators, cleaning agents and procedures used. The reprocessing instructions reported in the present document have been validated by Orthofix Srl and they are in accordance with the following standards and TIR AAMI: - AAMI TIR12 - AAMITIR 30 - ISO 17664 - ISO 17665 - ISO 15883 - ISO 11607 - ASTM E1837 - EN 14885 It is responsibility of the health care facility to ensure that the reprocessing is performed in accordance with the instructions provided. Alternative methods of reprocessing are allowed, but it is the responsibility of the health care facility to validate and monitor the process. Any deviation from the instructions provided by Orthofix Srl must be validated by the end user.

Warnings • Devices labeled “FOR SINGLE USE ONLY” can be reprocessed multiple times before their first clinical use but must not be reprocessed for re-use in a clinical setting. • Single use devices MUST NOT BE REUSED, as they are not designed to perform as intended after the first usage. Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or material leading to diminished safety, performance and/or compliance with relevant specifications. Please refer to the device label to identify single or multiple use and/or cleaning and re-sterilization requirements. • The personnel that works with contaminated medical devices must follow safety precautions as per the procedure of the healthcare facility. • Cleaning and disinfection solutions with a pH 7-10.5 are recommended. Cleaning and disinfection solutions with a higher pH should

•

be used according to the material compatibility requirements stated on the detergent technical data sheet. Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used. Contact with saline solutions should be minimized. Complex devices such as those with hinges, lumens or mated surfaces must be thoroughly manually pre-cleaned before automated washing in order to remove soiling that accumulates in recesses. If a device needs particular care in precleaning, a product specific IFU is available on the Orthofix website, which is accessible using the datamatrix reported on the product labelling. DO NOT use metal brushes or steel wool.

Limitations on reprocessing • Repeated reprocessing has minimal effect on reusable fixators and instruments. • End of life is normally determined by wear and tear due to use. • Products labeled for Single Use only MUST NOT be reused regardless of any reprocessing in a clinical setting.

3

4

Processing Instructions

Processing Instructions Steps to prepare a reusable medical device for re-use are summarized in the following chart. More detailed instructions for each cleaning step are given in the following chapter.

Point of Use

Transport to Processing Area

• Cover instruments to minimize the risk of cross contamination • Follow hospital protocols

Preparation for Cleaning

• Disassemble where required

Pre-Cleaning

• Remove gross soil • Soak in cleaning solution • Brush, operate moving parts • Rinse in running water • Inspect, place on absorbent paper

Automatic (recommended)

Manual

Manual Cleaning and Disinfection

• Put the device in cold water (< 40°C or < 104°F) or a neutral pH cleaning solution for at least 10 minutes removing gross soil with soft cloth or soft brush • DO NOT USE FIXATING DETERGENT OR HOT WATER

• Soak the single components in the cleaning solution • Thoroughly scrub the single component • Rinse with purified water • Soak in disinfectant solution • Rinse with purified water • Inspect • Dry

Automated Cleaning and Disinfection in Washer-Disinfector

Inspection

• Visual inspection • Functional check

Sterilization

• Suitable Packaging • Steam autoclave

Storage

• Control environment • Control shelf life

• Perform a manual cleaning if the component has lumens or complexity • Load into washer-disinfector • Connect cannulations to the proper injector jets • Operate washer-disinfector cycle validated • Rinse with purified water • Inspect • Dry

Preparation for Cleaning

Point of Use Reprocess the reusable medical devices as soon as is reasonably practicable in order to minimize the drying of soil and residuals. For optimal results, instruments should be cleaned within 30 minutes of use. DO NOT use a fixating detergent or hot water because this can cause the fixation of residue.

Containment and transportation Cover contaminated instruments during transportation to minimize the risk of cross contamination. All used surgical instruments must be regarded as contaminated. Follow the hospital protocols for handling contaminated and bio-hazardous materials. Handling, collection and transportation of used instruments must be strictly controlled to minimize any possible risks to patient, personnel and any area of the healthcare facility.

Preparation for Cleaning This pre-cleaning procedure can be omitted in case of direct subsequent manual cleaning and disinfection. In case of highly contaminated reusable medical device, before starting an automatic cleaning process, a pre-cleaning and a manual cleaning are recommended. Manual Pre-cleaning 1. Wear protective equipment and follow the safety precautions of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, and no visible foreign material can be present. 3. Fill the receptacle with sufficient detergent solution. Orthofix recommends the use of a slightly alkaline enzymatic detergent solution based on a detergent containing <5% anionic surfactants and enzymes, prepared using deionized water. 4. Carefully immerse the component in the solution in order to displace trapped air. 5. Scrub the device in the cleaning solution with a soft bristled nylon brush until all visible soiling is removed. Use a soft bristled nylon brush to remove residuals from lumens, rough or complex surfaces using a twisting motion. 6. Rinse cannulations with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Ultrasonic clean the single components in a degassed cleaning solution.

10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. Use a syringe in case of lumens or cannulations. 11. Remove item from rinse water and drain. 12. Carefully hand-dry using a clean, lint free cloth.

5

6

Cleaning

Cleaning General considerations Orthofix provides two methods of cleaning: a manual method and an automated method. Wherever applicable, the cleaning phase should start immediately after the pre-cleaning phase to avoid soil drying. The automated cleaning process is more reproducible and therefore more reliable, and the staff is less exposed to the contaminated devices and to cleaning agents used. Staff shall use protective equipment following the safety precautions to comply with the procedure of the healthcare facility. In particular, staff should take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. Observe all instructions provided by the detergent's manufacturer regarding the immersion time of the device in the cleaning agent/disinfectant and its concentration. The quality of the water used for diluting cleaning agents and for rinsing medical devices should be carefully considered. Manual cleaning 1. Wear protective equipment following safety precautions to comply with the procedure of the healthcare facility. 2. Ensure that the cleaning receptacle is clean and dry, and no visible foreign material can be present. 3. Fill the receptacle with sufficient cleaning solution. Orthofix recommends the use of a slightly alkaline enzymatic cleaning solution. 4. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the cleaning solution reaches all surfaces, including holes or cannulations. 5. Thoroughly scrub the device in the cleaning solution with a soft bristled nylon brush until all visible soiling is removed. Use a soft bristled nylon brush and a twisting motion to remove residuals from lumens, rough or complex surfaces. 6. Rinse cannulations at least three times with cleaning solution using a syringe. Never use metal brushes or steel wool. 7. Remove the device from the cleaning solution. 8. Brush the single components in running tap water. 9. Put single components in ultrasonic device with degassed cleaning solution. Orthofix recommends the use of a detergent solution based on a

detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionized water. Orthofix recommends on the basis of the validation performed to use an ultrasound frequency of 35 kHz, power = 300 Weff, for 15 minutes. The use of other solutions and parameters shall be validated by the user and the concentration shall be in compliance with the detergent’s manufacturer technical datasheet. 10. Rinse the components in purified sterile water until all traces of cleaning solution are removed. 11. Rinse the cannulations, rough or complex surfaces at least three times with purified sterile water. When cannulations are present use a syringe to facilitate this step. 12. Remove item from rinse water and drain. 13. If, after completion of the cleaning steps, some encrusted soil remains on the device, the cleaning step must be repeated as described above. 14. Carefully hand-dry using a clean, lint-free cloth. Manual disinfection 1.

Ensure that the cleaning receptacle is clean and dry, and no visible foreign material can be present. 2. Fill the receptacle with sufficient disinfectant solution. Orthofix recommends the use of a 6% hydrogen peroxide solution for 30 min prepared using water for injection. 3. Carefully immerse the component in the solution in order to displace trapped air; it is important to ensure that the disinfectant solution reaches all surfaces, including holes or cannulations. 4. Rinse cannulations, rough or complex surfaces at least three times with disinfectant solution. Use a syringe filled with disinfectant solution to rinse cannulations. 5. Remove the items from the solution and drain. 6. Soak in water for injection (WFI)to remove traces of disinfectant solution. 7. Rinse the cannulations at least three times with a syringe (filled with WFI). 8. Remove item from rinse water and drain. 9. Repeat the rinsing procedure as described above. 10. Carefully hand-dry using absorbent, non-shedding cloth. 11. Visually inspect and repeat manual cleaning and disinfection if necessary.

Maintenance, inspection and function testing

Automatic cleaning and disinfection using washerdisinfector 1.

Perform a pre-cleaning if necessary due to the contamination of the device. Take special care when the items have: a. Cannulations b. Long blind holes c. Mating surfaces d. Threaded components e. Rough surfaces 2. Use a washer-disinfector in compliance with EN ISO 15883 that is properly installed, qualified and regularly subjected to maintenance and testing. 3. Ensure that the cleaning receptacle is clean and dry, and no visible foreign material can be present. 4. Ensure that the washer-disinfector and all services are operational. 5. Load the medical devices into the washerdisinfector. Place heavier devices in the bottom of the baskets. Products must be disassembled before placing them in the baskets according to the specific instructions provided by Orthofix. Wherever possible, all parts of disassembled devices should be kept together in one container. 6. Connect cannulations to the rinsing ports of the washer-disinfector. If no direct connection is possible, locate the cannulations directly on injector jets or in injector sleeves of the injector basket. Orient instruments into the automated washer’s carriers as recommended by the washer manufacturer. 7. Avoid contact between devices because movement during washing could damage the devices and the washing action could be compromised. 8. Arrange medical devices so that cannulations are in vertical position and blind holes incline downwards to promote the leakage of any material. 9. Use approved thermal disinfection program. When using alkaline solutions, a neutralizer must be added. Orthofix recommends the following steps at a minimum: a. Pre-cleaning for 4 min. b. Cleaning with the appropriate solution. Orthofix recommends the use of a detergent solution based on a detergent containing <5% anionic surfactants, non-ionic surfactants and enzymes, prepared using deionized water for 10 min at 55°C. c. Neutralization with a neutralising agent solution. Orthofix recommends the use of a detergent solution based on citric acid, concentration 0.1%, for 6 min. d. Final rinsing with deionised water for 3 min.

e.

Thermal disinfection at least 90°C or 194° F (max 95 °C or 203° F) for 5 minutes or until A0 = 3000 is reached. The water used for thermal disinfection must be purified. f. Drying at 110°C for 40 minutes. When the instrument has a cannulation, an injector should be used to dry the internal part. The suitability of other solutions, concentration, time and temperature shall be checked and validated by the user following the detergent manufacturer's technical datasheet. 10. Select and start a cycle according to the recommendations of the washer manufacturer. 11. On completion of the cycle, ensure that all stages and parameters have been achieved. 12. Wearing protective equipment, unload the washer disinfector when it completes the cycle. 13. If necessary, drain excessive water and dry by using clean, lint-free cloth. 14. Visually inspect each device for remaining soil and dryness. If soil remains, repeat the cleaning process as described above.

Maintenance, inspection and function testing The following guidelines shall be applied to all Orthofix instruments that are labeled for multiple use. All functional checks and inspections described below also cover the interfaces with other instruments or components. The failure modes may be caused by end of life of the product, improper use or improper maintenance. Orthofix does not typically specify the maximum number of uses for re-useable medical devices. The useful life of these devices depends on many factors, including the method and duration of each use, and the handling between uses. Careful inspection and functional testing of the device before use is the best way to determine whether a device has reached its end of serviceable life. However, for certain instruments end of life has been defined, verified and specified with an expiration date. The following general instructions apply to all Orthofix products: • All instruments and product components must be visually inspected under good light for cleanliness. If some areas are not clearly visible, use a 3% hydrogen peroxide solution to detect the presence of organic residuals. If blood is present, bubbling will be observed. After the inspection, the device shall be rinsed and drained as the instruction given above. • If visual inspection evidences that the device was not properly cleaned, repeat the cleaning and disinfection steps or discard the device. • All instruments and product components must be visually inspected for any signs of deterioration

7

8 Maintenance, inspection and function testing

that may cause failure during use (such as cracks or damage to surfaces), and its functions must be tested before being sterilized. If a component or instrument is believed to be faulty, damaged or suspect, it must NOT BE USED. • Products that show excessive fading of marked product code, UDI and lot, thus preventing clear identification and traceability, must NOT BE USED. • Cutting instruments must be checked for sharpness. • When instruments form part of an assembly, check assembly with matching components. • Lubricate hinges and moving parts with an oil that does not interfere with steam sterilization as per manufacturer’s instructions before sterilization. Do not use silicone based lubricant or mineral oil. Orthofix recommends the use of a highly purified white oil composed by paraffinum liquidum of food and pharmaceutical grade. In order to give generic guidelines to check the proper functionality of the reusable medical device, Orthofix typically applies a “worst case” approach, i.e. the most challenging products are selected as representative products. The following generic product groups have been defined:

Group I Drilling Instruments

Group V Probe

Group II Cannulated Instruments

Group VI Instruments with a graduated scale

Group III Complex Instruments

Group VII General Instruments

Group IV Nail Handle

Group VIII Wrench

In Appendix I examples of the invasive reusable devices (i.e critical devices) of each family are listed. This list should be used as reference to classify the subject devices and is not meant to be exhaustive. The list is periodically updated when new devices are introduced in order to be as complete as possible. As a general preventive action Orthofix recommends following the instructions in the operative technique to avoid damage related to incorrect use. Specific instructions may be available for some product codes. These instructions are linked to the product code and are available on a dedicated Orthofix website. It is important to follow the cleaning procedure suggested by Orthofix to avoid damage related to incorrect handling.

Drilling Instruments

Drilling Instruments 17760 Cannulated Handle-Rasp D12/10

Possible damage

Prevention

Recommendations

• Dull sharps

• Regular functional check and visual inspection

• In case of failure, the instrument must be replaced and not be used

• Blunt and/or dull cutting flutes • Bent tip

9

10 Cannulated Instruments

Cannulated Instruments 11145 Ruland Pilot Wire Guide diameter 2mm length 115mm

Possible damage

Prevention

Recommendations

• Bent tube

• Regular functional check and visual inspection

• In case of failure, the instrument must be replaced and not be used

• Dents on the sleeve tip

Complex Instruments

Complex Instruments 166978 Extraction Pliers

Possible damage

Prevention

Recommendations

• Deformed functional surfaces (e.g. teeth and tip)

• Regular functional check and visual inspection

• In case of failure, the instrument must be replaced and not be used

• Corrosion between adjacent surfaces

• Follow the cleaning instruction reported on the IFU device

• Spring deformed

• Do not bend spring

• Damaged thread

• Do not overtighten the locking nut

• Handle blocked

• Use an appropriate instrument to test all moving parts and articulating surfaces when it is necessary

11

12 Nail Handle

Nail Handle 177100 Proximal Targeting Arm

Possible damage

Prevention

• Surgeon reference indications not visible

• Follow the cleaning instruction • In case of failure, the instrument reported on the IFU device. Follow must be replaced and not be used the mounting instruction during the assembly

• Cams broken off, bent or twisted • Damaged thread • Reference for mounting phase not visible

Recommendations

Nail Handle

Nail Handle 177120 Distal Targeting Arm

Possible damage

Prevention

• Reference for mounting phase not visible

• Follow the cleaning instruction • In case of failure, the instrument reported on the IFU device. Follow must be replaced and not be used the mounting instruction during the assembly

• Button cannot be completely pressed • Damaged pin

Recommendations

13

14 Probe

Probe OHP2061 6mm Piercer Probe 180mm

Possible damage

Prevention

Recommendations

• Bent tip

• Regular functional check and visual inspection

• In case of failure, the instrument must be replaced and not be used

• Damaged tip • Damaged thread

Instruments with a graduated scale

Instruments with a graduated scale 177300 Long Depth Gauge

Possible damage

Prevention

Recommendations

• Measuring hook bent out to alignment

• Insert gauge correctly

• In case of failure, the instrument must be replaced and not be used

• Measuring hook broken off • Scaling no longer visible • Stop gauge no longer stable

• Adequate care should be taken of the measuring hook

15

16 General Instruments

General Instruments 183336 M7 Conical Mallet Adaptor

Possible damage

Prevention

Recommendations

• Threads damaged, stripped or destroyed

• Do not subject the instruments to excessive force

• In case of failure, the instrument must be replaced and not be used

• Worn surfaces

• Ensure that instruments are connected correctly together

• Bent, damaged tip

Wrench

Wrench 17963 Cephalic Screwdriver II

Possible damage

Prevention

Recommendations

• Damaged threads

• Do not subject the instruments to excessive force

• In case of failure, the instrument must be replaced and not be used

• Cams broken off, bent or twisted • Hexagon head damaged • Hexagon bent

17

18 Packaging, Sterilization

Packaging

Sterilization

In order to prevent contamination after sterilization, Orthofix recommends using one of the following packaging systems: a. Wrap in compliance with EN ISO 11607, suitable for steam sterilization, and appropriate to protect the instruments or trays contained to mechanical damage. Orthofix recommends the use of a double wrap constituted of tri laminate non woven fabrics made of spunbond polypropylene and melt blown polypropylene (SMS). The wrap shall be resistant enough to contain devices up to 10kg. In the USA, a FDA-cleared sterilization wrap must be used and compliance with ANSI/AAMI ST79 is mandatory. In Europe, a sterilization wrap in compliance with EN 868-2 may be used. Fold the wrap to create a sterile barrier system according to a process validated as per ISO 11607-2. b. Rigid sterilization containers (such as Aesculap JK series rigid sterilization containers). In Europe, a container in compliance with EN 868-8 may be used. Do not include additional systems or instruments in the same sterilization container.

Steam sterilization according to EN ISO 17665 and ANSI/AMMI ST79 is recommended. Gas plasma, dry heat and EtO sterilization MUST BE avoided as they are not validated for Orthofix products. Use a validated, properly maintained and calibrated steam sterilizer. The steam quality must be appropriate for the process to be effective. Do not exceed 140°C (284°F). Do not stack trays during sterilization. Sterilize by steam autoclaving, utilizing a fractioned pre-vacuum cycle or gravity cycle according to the table below:

Every sterile barrier packaging not validated by Orthofix must be validated by individual health care facility according to instruction from the manufacturer. When equipment and processes different from that validated by Orthofix, the health care facility should verify that sterility can be achieved using parameters validated by Orthofix. Do not include additional systems or instruments in the sterilization tray. Note that sterility cannot be guaranteed if the sterilization tray is overloaded. The total weight of a wrapped instrument tray should not exceed 10 kg.

Steam sterilizer type

Gravity

Pre-vacuum

Pre-vacuum

Pre-vacuum

Notes

-

-

Not for use in US

WHO guidelines Not for use in US

Minimum exposure Temperature

132°C (270°F)

132°C (270°F)

134°C (273°F)

134°C (273°F)

Minimum exposure Time

15 minutes

4 minutes

3 minutes

18 minutes

Drying Time

30 minutes

30 minutes

30 minutes

30 minutes

Number of pulses

N/A

4

4

4

Orthofix recommends always using a pre-vacuum cycle for steam sterilization. The Gravity cycle was validated but is suggested only when no other options are available. The Gravity cycle was only validated for wraps and was not validated for sterilization in rigid containers.

Storage, Disclaimer, Notice about serious incidents

Storage Store the sterilized instrument in the sterilization packaging in a dry and clean environment at room temperature.

Disclaimer The instructions provided herein have been validated by Orthofix Srl for the preparation of a device for first clinical use or for re-use of multiple use devices. It remains the responsibility of the reprocessing officer to ensure that the reprocessing, as actually performed using equipment, materials and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process. The cleaning, disinfection and sterilization processes must be adequately recorded. Any deviation by the reprocessing officer from the instructions provided must be properly evaluated for effectiveness and potential adverse consequences, and must also be appropriately recorded.

Cleaning Agent Information Orthofix used the following cleaning agents during validation of these processing recommendations. These cleaning agents are not listed in preference to other available cleaning agents which may perform satisfactorily. • For manual precleaning: Neodisher Medizym concentration 2% • For manual cleaning: Neodisher Mediclean concentration 2% • For automated cleaning: Neodisher Mediclean concentration 0,5%

Notice about serious incidents Report any serious incident involving a device to Orthofix Srl and the appropriate governing body in which the user and/or patient is established.

19

20 Appendix I

Appendix I This list should be used as reference to classify the subject devices and is not meant to be exhaustive. Here are reported examples of critical medical devices. The list is periodically updated when new devices are introduced.

Drilling Instruments

Code

Description

Code

Description

13001

DRILL BIT KIT DIAMETER 2.9MM LENGTH 140MM

DH0476

2.5MM QUICK READ DRILL BIT, LAPIDUS SYSTEM

13003

DRILL BIT KIT DIAMETER 3.2MM LENGTH 140MM

1-TP1104

DRILL BIT (D. 3.2MM) QUICK CONNECT

1-1100201

177283

6.1MM DRILL FOR THREADED HEAD SCREW

1-1100301

177284

4.3MM FREEHAND DRILL

1-1100701

177286

4.3MM CALIBRATED DRILL

1-1100401

177287

7MM ENTRY DRILL

1-1102101

177288

9MM ENTRY DRILL

1-1102701

177289

13MM ENTRY REAMER

17426

T-HANDLED REAMER D 4MM FOR TIBIAL NAIL

177292

COUNTERSINK

17472

NAIL RIGID REAMER D 7MM LENGTH 410MM

002-A-14010

CUP REAMER, 14MM, QUICK CONNECT

17473

NAIL RIGID REAMER D 8MM LENGTH 410MM

002-A-14011

CONE REAMER, 14MM, QUICK CONNECT

17474

NAIL RIGID REAMER D 9MM LENGTH 410MM

002-A-16010

CUP REAMER, 16MM, QUICK CONNECT

1-1103001

CALIBRATED DRILL BIT D.4MM L.180MM TIN COATED - QUICK CONNECT

002-A-16011

CONE REAMER, 16MM, QUICK CONNECT

99-1100901

DRILL BIT L280MM D4MM STERILE

002-A-18010

CUP REAMER, 18MM, QUICK CONNECT

17327

T-HANDLED REAMER DIAMETER 6MM FEMORAL NAIL

002-A-18011

CONE REAMER, 18MM, QUICK CONNECT

171080

FLEXIBLE REAMER D 8.0MM

002-A-20010

CUP REAMER, 20MM, QUICK CONNECT

171090

FLEXIBLE REAMER D 9.0MM

002-A-20011

CONE REAMER, 20MM, QUICK CONNECT

171095

FLEXIBLE REAMER D 9.5MM

193270

ENTRY REAMER

171100

FLEXIBLE REAMER D 10.0MM

193285

4.2MM DISTAL DRILL BIT - SHORT

171105

FLEXIBLE REAMER D 10.5MM

193286

4.2MM DISTAL DRILL BIT - LONG

171110

FLEXIBLE REAMER D 11.0MM

193970

LAG SCREW GRADUAL REAMER

171115

FLEXIBLE REAMER D 11.5MM

193971

SUPPLEMENTARY GRADUAL DRILL BIT

171120

FLEXIBLE REAMER D 12.0MM

193973

4MM CORTICAL DRILL

171125

FLEXIBLE REAMER D 12.5MM

187283

LARGE STEPPED DRILL D5.1-7.5MM

171130

FLEXIBLE REAMER D 13.0MM

187284

SMALL STEPPED DRILL D4-5.5MM

171135

FLEXIBLE REAMER D 13.5MM

183270

ENTRY REAMER

171140

FLEXIBLE REAMER D 14.0MM

183285

DISTAL DRILL BIT D3.2MM

171145

FLEXIBLE REAMER D 14.5MM

183978

PLIER CUTTER D15MM

171150

FLEXIBLE REAMER D 15.0MM

1-1355001

DRILL BIT D.2,7MM L.127MM TIN COATED - QUICK CONNECT

17326

DRILL BIT DIAMETER 6MM LENGTH 280MM

13550

DRILL BIT KIT DIAMETER 2.7MM LENGTH 127MM

11008

DRILL BIT KIT DIAMETER 4.0MM LENGTH 310MM

1-1100101

DRILL BIT D.4,8MM L.180MM TIN COATED - QUICK CONNECT

17640

COUNTERSINK HAND DRILL

11001

DRILL BIT KIT DIAMETER 4.8MM LENGTH 180MM

17760*

CANNULATED HANDLE-RASP D12/10

17765

GRADUATED DRILL 10/12MM

186000Q

GOTFRIED PC.C.P. 7,0MM DRILL BIT

1-1300101 1-1300301

DRILL BIT D.2,9MM L.140MM TIN COATED - QUICK CONNECT DRILL BIT D.3,2MM L.140MM TIN COATED - QUICK CONNECT

DRILL BIT D.4,8MM L.240MM TIN COATED - QUICK CONNECT DRILL BIT D.3,2MM L.200MM TIN COATED - QUICK CONNECT DRILL BIT D.4,8MM L.280MM TIN COATED - QUICK CONNECT DRILL BIT D.1,6MM L.90MM TIN COATED - QUICK CONNECT CALIBRATED DRILL BIT D.4,8MM L.190MM TIN COATED - QUICK CONNECT CALIBRATED DRILL BIT D.4,8MM L.280MM TIN COATED - QUICK CONNECT