Spine Cable System. Implants and instruments for use when stabilizing and reconstructing spinal structures.

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1 Spine Cable System. Implants and instruments for use when stabilizing and reconstructing spinal structures. Technique Guide s and implants approved by the AO Foundation

3 Table of Contents Introduction Spine Cable System 2 AO Principles 3 Indications 4 Surgical Technique Double-Lead Cable 5 Single-Lead Cable 11 Product Information s 15 Set List 16 Synthes Spine

Ti-6Al-7Nb alloy and stainless steel Retrieval loop at the end of the cable facilitates passing the cable sublaminarly Available in

4 Spine Cable System 1.0 mm diameter cable fabricated with an (8 x 7) + (1 x 19) weave designed for flexibility and control Cable assemblies available in Ti-6Al-7Nb alloy and stainless steel Retrieval loop at the end of the cable facilitates passing the cable sublaminarly Available in single- and double-lead configurations 8 outer bundles of 7 strands One central bundle of 19 strands Cross-sectional view of cable Double-lead cable Single-lead cable Cable retrieval loops Crimp integral to the cable 2 Synthes Spine Spine Cable System

5 AO Principles In 1958, the AO formulated four basic principles which have become the guidelines for internal fixation. 1 They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal is returning as much function as possible to the injured neural elements. 2 AO Principles as Applied to the Spine 3 Anatomic Alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable Internal Fixation Stabilization of the spinal segment to promote bony fusion. Preservation of Blood Supply Creation of an optimal environment for fusion. Early, Active Mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Müller, M. Allgöwer, R. Schneider, H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag Ibid. 3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer-Verlag Synthes Spine 3

6 Indications As with monofilament wire, the Spine Cable System is indicated for the following spinal applications: Spinal trauma for sublaminar, interspinous, or facet wiring; Spinal reconstruction to correct spinal deformities, scoliosis, kyphosis, and spondylolisthesis; and Spinal degenerative surgery as an adjunct to spinal fusions. Note: See package insert for intended use/indications, device description, contraindications, precautions, warnings, and potential risks associated with the Spine Cable System. 4 Synthes Spine Spine Cable System

Technique Double-Lead Cable Required Set 105.

745 Cable Retriever Pass the leader of the double-lead cable under the lamina

leader. Gently pull the cable through until the leader is completely exposed.

7 Technique Double-Lead Cable Required Set Spine Cable System Set 1 Pass the leader Cable Retriever Pass the leader of the double-lead cable under the lamina and use the Cable Retriever to catch the retrieval loop on the tip of the leader. Gently pull the cable through until the leader is completely exposed. 2 Cut the leader tip Cable Cutter Using the Cable Cutter, remove only the tip of the leader. Separate the cable leaders. Synthes Spine 5

744 Pretensioner Gently pull each cable sequentially for provisional tightening.

8 Technique Double-Lead Cable continued 3 Thread cable through the crimp Thread the cable leader through the crimp sleeve and pull up the slack in each cable. 4 Attach Pretensioner Pretensioner Gently pull each cable sequentially for provisional tightening. Next, depress the button on the side of the Pretensioner and pass the cable in the indicated direction. Releasing the button automatically locks the cable. 6 Synthes Spine Spine Cable System

on the cylindrical barrel. Gently squeeze the handle until a single click is heard.

6 Provisionally tighten the cable Pass the cable end through the spool at the end of the

9 5 Attach Tensioner/Crimper Tensioner/Crimper Align the jaws of the Tensioner/Crimper to grasp the crimp sleeve on the cylindrical barrel. Gently squeeze the handle until a single click is heard. Note: Typically, one click only is required to securely fasten the crimp. 6 Provisionally tighten the cable Pass the cable end through the spool at the end of the Tensioner/Crimper handle and pull any excess slack out of the cable. Note: The holes in the spool must be aligned with the line etched on the spool. Synthes Spine 7

Technique Double-Lead Cable continued 7 Adjust the torque setting 321.132 Torque Limiting Handle Select the desired torque by adjusting the setting on the Torque Limiting Handle.

Note: It is recommended to start at a lower torque setting; the setting can be increased as needed. 8 Tension the cable Attach the Torque Limiting Handle to the Tensioner/Crimper.

10 Technique Double-Lead Cable continued 7 Adjust the torque setting Torque Limiting Handle Select the desired torque by adjusting the setting on the Torque Limiting Handle. Grasp the knurled wheel on the handle and pull it toward the working tip. Rotate the wheel to the desired torque setting and release. Note: It is recommended to start at a lower torque setting; the setting can be increased as needed. 8 Tension the cable Attach the Torque Limiting Handle to the Tensioner/Crimper. Apply tension by rotating the Torque Limiting Handle in a clockwise direction until it slips. Slide the Pretensioner forward to maintain tension if the Tensioner/Crimper is to be removed. Note: Rotate the handle in the direction noted on the shaft of the Torque Limiting Handle. 8 Synthes Spine Spine Cable System

9 Tension the second cable Repeat steps 5 8 for the second cable. Remove the Torque Limiting Handle and the Tensioner/Crimper from the construct when tensioning is complete.

11 9 Tension the second cable Repeat steps 5 8 for the second cable. Remove the Torque Limiting Handle and the Tensioner/Crimper from the construct when tensioning is complete. Notes: The tension in each cable can be rechecked or increased sequentially a number of times. Alternatively, two Tensioner/Crimpers may be used in place of two Pretensioners. 10 Secure crimps Secure each crimp by grasping the crimp sleeve in the jaws of the Tensioner/Crimper and squeezing the handles until they automatically release. Note: This is a safety mechanism to ensure the sleeve is fully crimped. Remove the Tensioner/Crimper and Pretensioners. Synthes Spine 9

Technique Double-Lead Cable continued 11 Remove excess cable 391.905.

12 Technique Double-Lead Cable continued 11 Remove excess cable Cable Cutter Cut the cables flush with the tip of the crimp sleeves using the Cable Cutter. 10 Synthes Spine Spine Cable System

Technique Single-Lead Cable 1 Pass the leader 321.

the lamina and use the Cable Retriever to catch the retrieval loop

Gently pull the cable through until the leader is completely

13 Technique Single-Lead Cable 1 Pass the leader Cable Retriever Pass the leader of the single-lead cable under the lamina and use the Cable Retriever to catch the retrieval loop on the tip of the leader. Gently pull the cable through until the leader is completely exposed. 2 Cut the leader tip Cable Cutter Using the Cable Cutter, remove only the tip of the leader. Synthes Spine 11

Technique Single-Lead Cable continued 3 Thread cable through the crimp Thread the cable leader through the crimp sleeve and pull up the slack in the

Gently squeeze the handles until a single click is heard.

14 Technique Single-Lead Cable continued 3 Thread cable through the crimp Thread the cable leader through the crimp sleeve and pull up the slack in the cable. 4 Attach the Tensioner/Crimper Tensioner/Crimper Grasp the crimp sleeve with the jaws of the Tensioner/Crimper. Gently squeeze the handles until a single click is heard. 5 Provisionally tighten the cable Pass the cable end through the spool at the end of the Tensioner/Crimper handle and pull any excess slack out of the cable. Note: The holes in the spool must be aligned with the line etched on the spool. 12 Synthes Spine Spine Cable System

6 Adjust the torque setting 321.132 Torque Limiting Handle Select the desired torque by adjusting the setting on the Torque Limiting Handle.

Note: It is recommended to start at a lower torque setting; the setting can be increased as needed.

15 6 Adjust the torque setting Torque Limiting Handle Select the desired torque by adjusting the setting on the Torque Limiting Handle. Grasp the knurled wheel on the handle and pull it toward the working tip. Rotate the wheel to the desired torque setting and release. Note: It is recommended to start at a lower torque setting; the setting can be increased as needed. 7 Tension the cable Attach the Torque Limiting Handle to the Tensioner/Crimper. Apply tension by rotating the Torque Limiting Handle in a clockwise direction until it slips. Remove the Torque Limiting Handle. Synthes Spine 13

Remove the Tensioner/Crimper. 9 Remove excess cable 391.905.

16 Technique Single-Lead Cable continued 8 Secure the crimp Secure the crimp by squeezing the handles until they automatically release. Remove the Tensioner/Crimper. 9 Remove excess cable Cable Cutter Cut the cable flush with the tip of the crimp sleeve using the Cable Cutter. 14 Synthes Spine Spine Cable System

s 321.131 Tensioner/Crimper Automatically releases when the crimp is fully secured.

132 Torque Limiting Handle Tension level can be set using the adjustable Torque Limiting Handle 321.

17 s Tensioner/Crimper Automatically releases when the crimp is fully secured. Single instrument applies tension and crimps Torque Limiting Handle Tension level can be set using the adjustable Torque Limiting Handle Pretensioner Holds cable tension prior to crimping Cable Retriever Facilitates sublaminar cable passage Cable Cutter, standard Cuts cable flush with head of crimp Synthes Spine 15

Spine Cable Set (105.803) Graphic Case 690.036 Spine Cable System Set Graphic Case s 321.131 Tensioner/Crimper, 2 ea. 321.132 Torque Limiting Handle 321.

0 mm Cable with Crimp, 470 mm, sterile Stainless Steel Titanium 291.991.01S 491.991.01S single lead 291.992.01S 491.992.01S double lead 1.

For detailed cleaning and sterilization instructions, please refer to http://us.synthes.com/medical+community/cleaning+and+sterilization.

18 Spine Cable Set ( ) Graphic Case Spine Cable System Set Graphic Case s Tensioner/Crimper, 2 ea Torque Limiting Handle Pretensioner, 4 ea Cable Retriever Cable Cutter, standard Also Available 1.0 mm Cable with Crimp, 470 mm, sterile Stainless Steel Titanium S S single lead S S double lead 1.0 mm Cable with Crimp, single lead Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices s, Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ mm Cable with Crimp, double lead 16 Synthes Spine Spine Cable System

20 Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 6/10 J3510-D

2179-CD Series Fiber Optic Splice Closure. Installation Instructions

2179-CD Series Fiber Optic Splice Closure Installation Instructions 1.0 Product Introduction The new 3M TM 2179-CD Series Fiber Optic Splice Closure can be used in buried, underground, aerial, and pedestal