Cable System Instructions for Use

Instructions for Use Cable System

Trochanter Reattachment Devices (TRD), for Cable System

Cerclage Wires

Non-sterile

Sterile

Small

498.806

498.806S

Large

498.807

498.807S

B (mm)

Length (mm)

1

280

291.010.10*

1.25

280

291.020.10*

Instruments

1

600

291.030.10*

03.221.010

Cerclage Passer Ø 46 mm, minimally invasive

1.25

600

291.040.10*

03.221.011

Cerclage Passer Ø 60 mm, minimally invasive

0.8

280

291.080.10*

03.221.012S

Cable Passing Tube, L 400 mm

1.5

280

291.110.10*

391.201

Cable Tensioner

1.5

600

291.120.10*

03.221.015

Cable Tensioner, one-hand operable

0.4

150

291.220.10*

391.103

Cable Passer, medium, curved

0.6

175

291.240.10*

391.108

Cable Passer, large, 45° angle

0.8

200

291.260.10*

1

250

291.270.10*

1.25

300

291.280.10*

Note: * For single package order XXX.XXX.01 instead of XXX.XXX.10

Coil w/ Cerclage Wires

Products available non-sterile and sterile can be differentiated with the suffix “S” added to the article number for sterile products.

B (mm)

Length (mm)

0.4

8

291.044

1

10

291.050

1.25

10

291.060

0.6

8

291.070

0.8

10

291.090

1.5

10

291.130

B (mm)

Stainless Steel

Ti-6Al-7Nb (TAN)

L605 (CobaltChrome Alloy)

1

02.401.000S

–

–

1

298.800.01

498.800.01

–

1

298.800.01S

498.800.01S

–

1.7

298.801.01

–

–

1.7

298.801.01S

–

–

1.7

–

–

611.105.01

Tubercable w/Crimp

1.7

–

–

611.105.01S

Wire-Cable w/Crimp

The Synthes Cable System consists of an assembly of various devices such as cerclage wires, cerclage cables, positioning pins, inserts, eyes, reattachment devices as well as associated instruments such as cable passing tube, cerclage passer and cable tensioner.

Cerclage Cables

Important note for medical professionals and operating room staff: These instructions for use do not include all information necessary for selection and use of a device. Please read the instructions for use and the Synthes brochure “Important ­Information” carefully before use. Ensure that you are familiar with the appropriate surgical procedure. Device(s)

Material(s)

Standard(s)

Cerclage Wires

316L Stainless steel

ISO 5832-1 ASTM F138/F139

Cerclage Cable w/Crimp B 1.0 mm

Cables: Ti-6Al-7Nb (TAN) Crimp: TiCP-Grade 2

ISO 5832-11 ASTM F1295 ISO 5832-2 ASTM F67

Cerclage Cable w/Crimp B 1.7  mm

Cables: L605 (Cobalt-Chrome Alloy) Crimp: TiCP-Grade 2

ISO 5832-5 ASTM F90 ISO 5832-2 ASTM F67

Trochanter Reattachment Device

Plate: Ti-6Al-7Nb (TAN) Cables: L605(Cobalt-­ Chrome Alloy) Crimp: TiCP-Grade 2

ISO 5832-11 ASTM F1295 ISO 5832-5 ASTM F90 ISO 5832-2 ASTM F67

Positioning Pins Cerclage Fix Insert

TiCP-Grade 4

ISO 5832-2 ASTM F67

Cerclage Eye f/Screws B 3.5 mm & B 4.5 mm Cerclage Eye f/Hexagonal Socket

TiCP-Grade 2

ISO 5832-2 ASTM F67

Cerclage Wire w/Eye Coil w/Cerclage Wire

Cerclage Cable w/Crimp B 1.0 mm & B 1.7 mm

Cerclage Eyes B (mm)

Stainless Steel

TiCP

3.5

02.221.002S

04.221.002S

3.5

02.221.002.05

04.221.002.05

4.5

02.221.003S

04.221.003S

4.5

02.221.003.05

04.221.003.05

4

02.221.004S

04.221.004S

4

02.221.004.05

04.221.004.05

CerclageFix, CerclageFix Insert Stainless Steel

TiCP

281.001

–

281.001S

–

281.002

481.002

281.002S

481.002S

Positioning Pins Cerclage Eye f/Screws B 3.5 mm & B 4.5 mm Cerclage Eye f/Hexagonal Socket Cerclage Fix Insert

Positioning Pins Stainless Steel

TiCP

02.231.022

04.231.022

02.231.022S

04.231.022S

298.803.01

498.803.01

298.803.01S

498.803.01S

298.837

498.837

298.837S

498.837S

298.838.01

498.838.01

298.838.01S

498.838.01S

298.839

498.839

298.839S

498.839S

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Intended Use Cable Implants are intended for fixation or stabilization of bones in various anato­ mical regions by using standard cerclage or tension band technique. Cable and Wire Instruments are intended for bending, cutting, twisting or binding surgical wire and cable implants during orthopedic surgery. Synthetic Protection Devices are intended to be used to protect soft tissue and facilitate implant inser­tion during orthopedic surgery.

Indications Cable System (including Cerclage Wires): – Orthopedic trauma surgery (incl. periprosthetic fractures, femur fractures, olecranon fractures, patella fractures, humerus and ankle fractures) – Acromioclavicular dislocation – Hip and acetabular fractures – Prophylactic banding in total joint replacements – Temporary fixation during open reductions Trochanteric Reattachment Device: – Reattachment of the greater trochanter following osteotomy in total hip arthroplasty or fractures Cerclage Passer (including the Cable Passing Tube): – For general orthopedic trauma surgery involving the application of cerclage cables and wires – Periprosthetic fractures of the femur – Subtrochanteric fractures – Prophylactic banding in total joint replacement – Additional fixation – Temporary reduction

Contraindications Cable System: The cerclage cable B 1.0 mm may not be used for fractures of the femur, or for prophylactic banding during total joint replacements. There are no specific contraindications related to any other devices of this system. Cerclage Passer (for Cables and Wires): No contraindication specific to these devices.

Patient Target Group The product is recommended to be used in skeletally mature patients.

Intended User These instructions for use alone do not provide sufficient background for direct use of the device or system. Instruction by a surgeon experienced in handling these devices is highly recommended.

Performance Characteristics of the Device Synthes has established the performance and safety of Cable System, and that they represent state of the art medical devices to encircle prosthesis and bone fragments and provide tension to hold fragments in alignment and offer increased stability to adjacent fragments when used according to their instructions for use and labeling.

Potential Adverse Events, Undesirable Side Effects and Residual Risks – Adverse Tissue Reaction, Allergy/Hypersensitivity Reaction – Soft Tissue Damage (including Compartment Syndrome) – Malunion/Nonunion – Symptoms resulting from Implant Migration, Loosening, Bending, or Breakage – Injury to User – Pain or Discomfort – Neurovascular Damage – Infection – Damage to Surrounding Structures – Phlebitis – Bone Damage including Intra- and Post-Operative Bone Fracture, Osteolysis, or Bone Necrosis

Patient-related Factors A series of patient related factors may impact the clinical outcomes, including bone healing. The decision whether to use these devices in patients with such conditions must be made by the physician taking into account the risks versus the benefits to the individual patient. – Compromised vascularity in the intended site of implantation – Compromised soft tissue coverage and conditions – Abnormal bone quality – Overweight – Occupations or activities that may generate excessive amount of physical loads – Noncompliant patient – Potential allergy or foreign body sensitivity to any of the implant materials”

Sterile Device Sterilized using irradiation Store sterile devices in their original protective packaging, and do not remove them from the packaging until immediately before use. Do not use when packaging is damaged Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use, if the package is damaged or date of expiration has passed.

Single-use Device Do not reuse

Surgery is to take place according to the instructions for use following the recommended surgical procedure. The surgeon is responsible for ensuring that the operation is carried out properly. It is strongly advised that the surgery is performed only by operating surgeons who have acquired the appropriate qualifications, are experienced in orthopedic surgery, are aware of general risks of orthopedic surgery, and are familiar with the product-specific surgical procedures.

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

This device is intended to be used by qualified health care professionals who are experienced in orthopedic surgery e.g. surgeons, physicians, operating room staff, and individuals involved in preparation of the device.

Furthermore, reuse or reprocessing of single-use devices may create a risk of ­contamination e.g. due to the transmission of infectious material from one patient to another. This could result in injury or death of the patient or user.

All personnel handling the device should be fully aware that these instructions for use do not include all the information necessary for selection and use of a device. Please read the instructions for use and the Synthes brochure “Important Information” carefully before use. Ensure that you are familiar with the appropriate surgical procedure.

Contaminated implants must not be reprocessed. Any Synthes implant that has been contaminated by blood, tissue, and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol. Even though used and contaminated implants may appear undamaged, the implants may have small defects and internal stress patterns that may cause material fatigue.

Reuse or clinical reprocessing (e.g. cleaning and resterilization) of soiled devices may compromise the structural integrity of the device and/or lead to device failure which may result in patient injury, illness or death.

Expected Clinical Benefits Expected clinical benefit of internal fixation devices such as cable implants when used according to instructions for use and recommended technique is achievement of bone union. A summary of safety and clinical performance can be found at the following link (upon activation): http://ec.europa.eu/tools/eudamed Note: The EUDAMED link will only be available after the European database on medical devices, EUDAMED, is launched.

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Warnings and Precautions

Magnetic Resonance Environment

Cable System: – The tension of the cerclage cable should not exceed 40 kg (for the cable B 1.0 mm) and 50 kg (for the cable B 1.7 mm). – Repeated tensioning of the cable at high loads may cause fraying of the cable. – The correct material composition is important. Use a Stainless Steel cable only with Stainless Steel implants, and the CoCr and Titanium cable only with Titanium implants. – Do not thread the cerclage cable through the shaft hole since the crimp will prevent removal of the cable passer. – Incorrectly placing the cable crimper can lead to crimp failure. – Make sure to cut the cable close to the crimp and in one action to avoid sharp edges. – Do not cut the Kirschner wires with the cable cutter since this can damage the cutting edges. – The cables should not be passed around a prosthesis. – The middle cable should be threaded first. – Do not thread the cable into the shaft hole of the cable passer, since the cable crimp and TRD, which are attached to the other end of the cable, will prevent release of the cable passer. – Take care not to exceed 50 kg of tension. Applying more tension may cause the cable to cut through soft or osteoporotic bone. – Visually check that the cable crimp is centered and fully seated in the jaws of the crimper prior to crimping the cable. Improper placement may lead to cable slippage or crimp failure. – Each cable should be cut as closely to the TRD as possible, taking care not to damage the adjacent cable.

Torque, Displacement and Image Artifacts are according to ASTM F 2213-06, ASTM F 2052-14 and ASTM F 2119-07: Non-clinical testing of worst-case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the ­Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Cerclage Passer: – Be careful to apply less tension in osteoporotic bone. – Do not use pliers for cable passing tube insertion due to tube damages. The cable passing tube must exit the opposite part of the cerclage passer. – The correct material composition is important. Use a Stainless Steel wire only with Stainless Steel implants. – The correct material composition is important. Use a Stainless Steel cable o ­ nly with Stainless Steel implants, and the CoCr and Titanium cable only with ­Titanium implants. – Application of cerclage wires/cables using a minimally invasive (MIS) technique requires a keen understanding of the neurovascular anatomy. – To prevent damage do not apply too much force while inserting the cerclage passer. Deformation of the tubes can result in nonclosure of the instrument when connecting the halves. – When the cerclage passer is in use, pay attention to the sterile field. – While connecting the two parts, the tips must not meet. Do not attempt to close the forceps as long as the middle of the forceps is not connected properly. – When closing the cerclage passer, be careful not to damage any soft tissue structures. Where necessary, enlarge the approach to verify that no soft tissue structures (mainly the neurovascular structures) are being damaged. Never push the handles medial to bring the halves together; instead, pull them towards the medial cortex. Close the forceps without using force. – Make sure to cut the wire close to the crimp and in one action to avoid sharp edges. – Make sure to cut the cable close to the crimp and in one action to avoid sharp edges. One-hand operable Cable Tensioner (03.221.015): – Repeated tensioning of cables at high loads may cause fraying of the cable. – The tension of the cable should not exceed 40 kg for the cable B 1.0 mm and 50 kg for the cable B 1.7 mm. High tension may cause the cable to tear out of the crimp or cut through soft or osteoporotic bone.

Combination of Medical Devices Synthes has not tested compatibility with devices provided by other manufacturers and assumes no liability in such instances.

Radio-Frequency-(RF-) induced heating according to ASTM F 2182-11a Non-clinical electromagnetic and thermal testing of worst-case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes­ [1.5 T] and for 15 minutes [3 T]). Precautions: The above-mentioned test relies on non-clinical testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients undergoing MR scanning for perceived temperature and/or pain sensations. – Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning procedures. – Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible. – Using the ventilation system may further contribute to reduce temperature increase in the body.

Treatment Before Device is Used Sterile Devices: Store sterile devices in their original protective packaging, and do not remove them from the packaging until immediately before use. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use, if the package is damaged. Non-sterile Devices: Synthes products supplied in a non-sterile condition must be cleaned and steam-­ sterilized prior to surgical use. Prior to cleaning, remove all original packaging. Prior to steam-sterilization, place the product in an approved wrap or container. Follow the cleaning and sterilization instruction given by the Synthes brochure “Important Information”.

Implant Removal In case the physician decides to remove the implants, implants can be removed by using general surgical Instruments.

Troubleshooting Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

Clinical Processing of the Device Detailed instructions for processing of implants and reprocessing of reusable devices, instrument trays and cases are described in the Synthes brochure ­ ­“Important Information”. Assembly and disassembly instructions of instruments “Dismantling multipart instruments” are available on the website.

The Cable System can be used in conjunction with the following devices according to the respective indication:

Disposal Any Synthes implant that has been contaminated by blood, tissue, and/or bodily fluids/matter should never be used again and should be handled according to hospital protocol.

VA-LCP Condylar Plate 4.5/5.0 LCP Locking Compression Plate 3.5/4.5/5.0

Devices must be disposed of as a healthcare medical device in accordance with hospital procedures.

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Special Operating Instructions Cable Tensioner (391.201):

Lubrication points

Possible Damage Jamming Prevention Inspect tensioner after and before each use. Recommendation Always lubricate collet tips (both sides) and threads with 2 to 3 drops of DePuy Synthes autoclavable oil (e.g. 519.970) after cleaning. Cable Tensioner, one-hand operable (03.221.015):

Lubrication points

Lubrication Always lubricate all springs, ratchets and levers with DePuy Synthes autoclavable oil (e.g. 519.970) after cleaning.



Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland Tel: +41 61 965 61 11 www.jnjmedicaldevices.com Instructions for Use: www.e-ifu.com

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