Reprocessing , Cleaning , Sterilization and Inspection of Non-Sterile Family Group 2 Devices

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Product Description

Product Description

Inspection for Completion

These instructions apply to all CADENCE Total Ankle System reusable medical devices that are sold by ASCENSION◊ Orthopedics, Inc. that are initially supplied non-sterile. These instructions also apply to single use medical devices that are supplied non-sterile and require processing. Non-sterile, single use medical devices (i.e., screws, pins, drills) are commonly placed in containment devices and therefore, require processing prior to use. The medical devices are intended for use in orthopedic surgical procedures according to the Instructions for Use and Surgical Techniques for the associated implant system. Use with devices other than those identified in the instructions for use and surgical techniques is not recommended. ◊

Intended Users The Ascension Orthopedics, Inc. CADENCE Total Ankle System devices are intended to be used by orthopedic surgeons with thorough knowledge of the anatomy, physiology, and surgical principles involved. Physicians are strongly encouraged to obtain instruction from experienced clinicians or to observe surgical use of the subject devices. The use environment is a professional healthcare facility.

Intended Use/Indications, Contraindications and Patient Target Group Intended use/indications, contraindications and patient target group are based on the implant devices and therefore information related to indications for use and contraindications can be found in the associated implant system Instructions for Use.

Warnings and Precautions U.S. Federal law restricts this device to sale by or on the order of a physician. • The devices are shipped non-sterile. Devices may require disassembly before reprocessing as indicated by the tray configuration and/or as indicated in the Instruction for Use and re-assembled prior to use as per the applicable Surgical Technique. Cleaning, disinfection and sterilization is required before each use.

• Read these instructions completely prior to use. The healthcare professional should have a full understanding of the product labeling information including, but not limited to, the following: Instructions for Use (IFU) for the implant, surgical techniques and other relevant product materials that have been provided by the manufacturer.

• Case bases, lids and inserts that are intended for the housing of non-sterile devices during transport, reprocessing and/or storage • Non-invasive instruments including clamps, rods, rod connectors, translation blocks, hammers, connectors, handles, and bisecters

• The patient should be warned of surgical risks and made aware of possible adverse effects. It Is recommended that the operating surgeon record all information given to the patient.

Materials These devices do not contain phthalates, CMR (carcinogenic, mutagenic or toxic to reproduction) or endocrine disruptive substances nor tissues of biological origin above the acceptable concentration of 0.1% weight by weight (w/w) unless indicated on the label.

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Orthopaedic surgical procedures follow a precise order in which the instruments are used. Also, many instruments have dimensional features which govern bone resections, determine implant sizes, and measure intramedullary canal sizes, depth of drill holes, angles of plate, etc. Therefore, it is very important that all requested sizes of a specific instrument series are available (specific instruments are routinely omitted from instrument sets due to infrequent use unless requested by the user). Contact your Ascension Orthopedics representative if requested instruments have been omitted but are required for surgery.

• It is the healthcare professional’s responsibility to be familiar with the appropriate surgical techniques prior to use of the device(s).

EU MDR Class I devices include:

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Upon receipt in the hospital, instrument sets should be inspected for completeness. Inspect for removable screws; detachable handles; and auxiliary exchangeable parts. Many organizing cases have shadow graphs, outlines, catalog numbers, and instrument names or sizes silk-screened or otherwise marked on the case or tray.

• Prior to each use, inspect the device for proper orientation and ensure it is functioning properly and not damaged. Do not use a bent or damaged device. Contact Ascension Orthopedics representative for repair or replacement of damaged items. • For single use devices, after use, the device may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

CADENCE◊ Total Ankle System Non-Sterile Device Reprocessing, Instructions For Use

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• Do not resharpen instruments. • Instruments should not be used with speeds exceeding the instrument manufacturer’s specifications. • Be cautious of pins loosening or backing out while performing sawing steps. • Any single use/disposable instrument, once used, should be discarded according to hospital policy. • Do not reuse single use instruments, reuse of disposable instruments may result in damage to single use or reusable instruments. • The instructions provided in this reprocessing manual have been validated by ASCENSION◊ Orthopedics, Inc. and are capable of preparing orthopedic devices for use. It is the responsibility of the hospital to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences. • 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 test of the device before use is the best method of determining the end of serviceable life for the medical device. Do not use devices that show evidence of damage and wear. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e. rust, pitting), discoloration, excessive scratches, flaking, wear and cracks. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated devices. PPE includes: gown, mask, goggles or face shield, and shoe covers. • Universal precautions are standards of infection control practices designed to reduce the risk of transmission of bloodborne infections. Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated devices. Exercise caution when handling devices with sharp points or cutting edges. • Eye protection for operating room personnel is recommended during use. • Protect Patient tissue at all times.

Cleaning and Sterilization Warnings

Cleaning and Sterilization Warnings • Single-use devices must not be reused. Use of a device is defined as contact of the device with blood or bodily fluids from a patient. Reuse may increase risk of breakage, failure, patient infection, patient injury and revision surgery. Refer to the device label to identify single-use devices. • It is the responsibility of the user to ensure that the sterilization process is performed using qualified equipment, materials and personnel such that the recommended parameters are achieved. • All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Manual cleaning should be done while the instrument is immersed. • Rinse aids can leave residues and is not recommended. • Always observe the cleaning agent concentrations, temperatures, contact times and final rinse instructions specified by the manufacturer. • For ultrasonic cleaning, the enzymatic detergent solution should be changed before it becomes heavily soiled so that effective cleaning is not inhibited. • Do not sonicate powered devices. • It is the responsibility of the user to ensure that the sterilization process is performed using qualified equipment, materials and personnel such that the recommended parameters are achieved. • Steam sterilization is the only method that has been validated for processing by Ascension Orthopedics. Sterrad or hydrogen peroxide-based gas systems have not been validated. • These recommended procedures are intended as a general guide for sterilization of reusable medical devices sold by Ascension Orthopedics Inc. Some devices are labeled with more specific instructions. • It is the responsibility of the user to validate their sterilization equipment to ensure that the recommended parameters are achieved. Steam sterilizers should be validated to local standards, guidance and ISO 17665. • It is the responsibility of the user to ensure that the cleaning process is performed following these procedures to achieve the desired result.

Adverse Event Reporting If, during the use of the device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.

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Storage, Handling and Disposal

Storage, Handling and Disposal • Reusable devices that will be stored between cleaning and sterilization should be dry to prevent microbial contamination that could result from wet devices. Containment devices can be stacked for storage. Store in a dry dust-free place. • Storage of devices after cleaning and sterilization should be in designated, limited access areas that are well ventilated and provide protection from dust, moisture, insects, vermin and temperature and humidity extremes.

• Be sure to arrange the items so that the water can easily flow out of cannulations, blind holes, and cavities. • For instruments with long or narrow lumens, standard processing should be used only if the disinfectant can flow easily through the lumens and safe rinsing is guaranteed. • The cases/trays used for cleaning must always be loaded correctly to ensure proper cleaning.

• Storage is event related and not time related.

• After cleaning, check instruments for cleanliness (visible dirt). This especially applies to cannulated instruments or those with blind holes and crevices.

• ASCENSION◊ Orthopedics does not recommend stacking of wrapped containment devices or rigid containers.

• To ensure proper instrument functioning, verify that all movable parts have been thoroughly cleaned.

• Reusable devices that have been inspected and have reached the end of their lifetime should be sterilized, if possible, and disposed according to institutional procedures. Single use devices should be disposed of according to institutional procedures, after use. Devices that are unable to be sterilized before disposal should be disposed properly as a potential biohazard.

• Pay special attention to slots, ratchets, joints and box locks, narrow lumens, blind holes, and other areas that are hard to access. • Deionized or distilled water should be used for the final rinse. Note: following cleaning, the instruments must be macroscopically clean, i.e. free from visible dirt or deposits. All movable parts, working tips and blades should be inspected with particular care. After cleaning, visually inspect devices under normal lighting for the removal of visible debris. Repeat cleaning if not visibly clean and reinspect the device.

• No hazardous substances are contained or come in contact with the device, components, or raw materials. Therefore, the risk of environmental impact upon proper disposal of the subject devices is considered negligible. The subject devices have not been evaluated for long term environmental impact.

Manual Cleaning Instructions

Preparation/General Guidance For Cleaning

The following steps should be completed in sequence. Please note that all instructions provided are validated. Depending upon the detergent selection, minimum processing times and temperature settings may need to be adjusted for optimal processing:

Verify that all instruments required for use are present in the case. It is not recommended to use chloride containing cleaning solutions since its use has been linked to corrosion of metallic instruments, especially stainless steel. Please also note the following: • Disinfect and clean devices immediately after use in order to avoid device encrustations.

1. Prepare a neutral pH enzymatic detergent as per the manufacturer’s recommendation (e.g. Enzol® prepared at 1 oz. per gallon of lukewarm deionized water). 2. Disassemble instruments to lowest level.

• Use a suitably sized non-metallic bristle brush for cleaning lumens, cannulations, blind holes, and cavities, making sure that every part of the inner surface can be properly accessed.

3. Rinse devices under lukewarm running water to remove all gross soil. Use a soft bristled brush to aid in the brushing. Agitate the instruments under the running water. Agitation includes actuating all movable parts such as opening and closing hinges and moving the instruments around under the running water. Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of instruments. Use a syringe to flush any lumens.

• Clean jointed instruments in closed as well as open positions.

4. Fully immerse each device in the prepared detergent and allow it to soak for a minimum of two minutes.

• Solutions used for cleaning must always be prepared in accordance with the manufacturer’s instructions. • Never use metal brushes or metal sponges for manual cleaning.

• Disassemble instruments as far as possible before cleaning.

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CADENCE◊ Total Ankle System Non-Sterile Device Reprocessing, Instructions For Use

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Automated Cleaning and Disinfection Instructions

5. After soaking the devices, and while still immersed, use a syringe to flush all hard to reach areas/lumens with the prepared detergent. Use a pipe cleaner brush to clean all hard to reach areas and/or lumens of each article. Use a soft bristle brush and circular strokes to remove any visible soil. Pay particular attention to all the areas where the soil could be imbedded (i.e. grooves, crevices, lumens, blind holes). Bend flexible components to their maximum amount in all orientations during this step. Note: Cleaning is performed under the surface of the prepared detergent solution to limit aerosolization of the cleaning fluid and soil, as well as for worker and environmental safety. 6. Use a syringe to flush lumens and a pipe cleaner to clean lumens and holes. 7. Remove articles from the detergent, and rinse devices under running lukewarm water for a minimum of one and a half (1.5) minutes to remove any detergent residuals. In accordance with Step 3, agitate the devices under the running water, being sure to actuate all movable parts, and using a soft bristled brush for internal and exterior device surfaces. Use a syringe to flush all hard to reach areas and/or lumens with water. 8. Prepare a neutral pH enzymatic detergent (eg. Enzol) in a sonicator, as per the manufacturer’s recommendation using lukewarm water. Fully immerse the devices in the detergent. Flush the articles with a syringe and actuate to ensure no air bubbles are trapped within the device. Bend flexible components to their maximum amount in all orientations during this step. Sonicate for 10 minutes. 9. After sonication, remove articles from the detergent and rinse the devices with running lukewarm water (use the highest grade of water available, distilled or deionized water is recommended) for three (3) minutes. Agitate the devices under the running water, being sure to actuate all movable parts. Use a clean soft bristled brush and/or pipe cleaner to aid in the rinse of internal and exterior device surfaces. Use a syringe to flush all lumens and hard to reach areas within the device.

Automated Cleaning and Disinfection Instructions The following steps should be completed in sequence. Please note that all instructions provided have been validated. The disinfection validation protocols were performed in accordance with ISO 15883-1: 2009 Washer-disinfectors, Part 1; General requirements, terms and definitions and tests and ISO 15883-2:2006 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.: Note: steps “1-6” listed below are manual pre-clean steps which need to be followed prior to step “7”. 1. Prepare an enzymatic detergent using lukewarm deionized water as per the manufacturer’s recommendation. 2. Fully immerse the devices and allow to soak for a minimum of two (2) minutes. 3. Following the soak time, flush any lumens of the device using a syringe. 4. Rinse the devices under lukewarm running deionized water for a minimum of one (1) minute, while agitating the devices. Agitation includes actuating all movable parts, such as opening and closing hinges and moving the devices around under the running water. 5. Use a clean soft bristled brush and/or pipe cleaner to brush and aid in the rinse for the exterior and interior of device components. Use a syringe to flush any lumens. 6. Place the devices back into the designated locations of the case/tray, and load the case/tray set into an automated washer/ washer disinfector (Steris 444 or equivalent). 7. The washer cycle parameters for automated cleaning are as follows:

10. Dry the devices using filtered pressurized air and visually examine to determine if all adherent visible soil has been removed. 11. Repeat the above cleaning procedure, if visible debris is detected.

Recirculation Time (Min.)

Water Temperature

Detergent

02:00

Cold Water

NA

01:00

Hot Water

Enzymatic Cleaner

Wash

02:00

60°C

Rinse

10:00

Hot Water*

Phase PreWash Enzyme Wash

Neutral Detergent NA

*Note: The highest grade of water available should be used during the final rinse cycle, distilled or deionized water is recommended.

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Inspection and Functional Check Prior to Use

8. The washer disinfector cycle parameters for automated cleaning and thermal disinfection are as follows: Phase

Recirculation Time (Min.)

Water Temperature

Pre-Wash 02:00 Enzyme 01:00 Wash

Cold Water

Wash

60°C

02:00

Hot Water

Inspection and Functional Check Prior to Use

Detergent

Following reprocessing and prior to use in surgery, all devices should be inspected to ensure proper function.

NA Enzymatic Cleaner Neutral Detergent

Markings on instruments used for measuring anatomical dimensions must be legible. These may include gauge markings, angles, inner or outer diameters, length or depth markings, and right/left indications. Notify your ASCENSION◊ Orthopedics representative if scales and other markings are not legible.

Thermal 10:00 82°C* NA Rinse *Note: The highest grade of water available should be used during the final rinse cycle, distilled or deionized water is recommended.

Additional details regarding inspection and functional check specific to device type or features are provided below:

9. After washing and disinfecting, dry the devices using a clean lint free cloth and visually examine to determine if all adherent visible soil has been removed. 10. Repeat the cleaning procedure if visible debris is detected.

• All reusable devices: Visually inspect for damage or wear, including components in their disassembled state prior to re-assembly. Ensure components are re-assembled securely. • Hinged devices: Check for smooth movement of the hinge without excessive “play.” • Locking mechanisms: Check for action. • Cutting features: Check edges for distortion and/or large nicks. Edges should be continuous. • Trials: Articular surfaces should be smooth and free of cracks and deep nicks. • Mating parts: Check to make sure that mating parts fit together without complications. Ensure components are re-assembled securely. • Reamer/drill bits: Inspect “chuck” end for burrs and distortion that might hinder insertion into a drill. • Hammering surfaces: Inspect for burrs and large nicks. • Driving devices: Inspect plastic ends for cracks and large nicks. • Metal surfaces: Inspect for corrosion and major deformation. • Powered devices: Verify that power is supplied when the device is turned on and ceases when the device is turned off. • Measuring devices (i.e. gauges, calipers): Check for legible measuring markings.

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CADENCE◊ Total Ankle System Non-Sterile Device Reprocessing, Instructions For Use

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Sterilization Instructions

Sterilization Instructions Sterilization validations were completed for our instrument sets. The validation protocols were performed in accordance with ANSI/AAMI ST79:2017 Steam Sterilization and Sterility Assurance in Health Care and ANSI/AAMI ST77: 2013/(R)2018 Containment Devices for Reusable Medical Device Sterilization, ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. All testing was done using the overkill approach with Geobacillus stearothermophilus spores. The results confirmed 106 Sterility Assurance Level (SAL) for the sets when using the recommended cycles. In accordance with our validation results, the following cycles are recommended for wrapped goods utilizing FDA-cleared sterilization wrap:

Recommended Sterilization Parameters Device Set System

Pre-vacuum

Gravity

Pre-vacuum1

Pre-vacuum1

132°C/4 Min.

132°C/15 Min.

134°C/3 Min.

134°C/18 Min.

Dry Time Requirements (minutes)

1

Case for Resection Instruments Case for Trials, Insertion and Removal Instruments Case, Flat Cut Instruments

30

30

30

30

30

30

30

30

30

30

30

30

Case, Flat Cut Instruments, Alternate

30

30

30

30

134°C setting is for use outside the USA only.

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Glossary of Symbols

Glossary of Symbols Manufacturer Date of manufacture Batch code

CE mark

Medical Device

Non-sterile

Authorized representative in the European community

Do not re-use MATL SS

Catalog number Quantity

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, TX 78758 USA 8

Integra LifeSciences Services Integra LifeSciences Corporation Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest – France Phone: +33 (0) 4 37 47 59 10

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Consult instructions for use

Stainless steel Made in the United States of America

Prescription use only

Trademark of Smith+Nephew All trademarks acknowledged

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www.smith-nephew.com ifu.smith-nephew.com +1 800 654 2873 Telephone +1 800 980 7742 Fax

©2021 Smith & Nephew, Inc. All rights reserved. 2021-12

CADENCE◊ Total Ankle System Non-Sterile Device Reprocessing, Instructions For Use