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  9. Synthes Spine Cable System Quick start guide

Synthes Spine Cable System Quick start guide

Instruments and implants
approved by the AO Foundation
Spine Cable System. Implants and
instruments for use when stabilizing
and reconstructing spinal structures.
Technique Guide
Introduction
Surgical Technique
Product Information
Table of Contents
Spine Cable System 2
AO Principles 3
Indications 4
Double-Lead Cable 5
Single-Lead Cable 11
Instruments 15
Set List 16
Synthes Spine
Cable retrieval loops
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
2Synthes Spine Spine Cable System
Cross-sectional view of cable
8 outer bundles
of 7 strands
One central
bundle of
19 strands
Crimp integral to the cable
Double-lead cable
Single-lead cable
AO Principles
Synthes Spine 3
In 1958, the AO formulated four basic principles which have
become the guidelines for internal fixation.1They 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 Spine3
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. 1991.
2. Ibid.
3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin;
Springer-Verlag. 1998.
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.
4Synthes Spine Spine Cable System
Technique — Double-Lead Cable
Required Set
105.803 Spine Cable System Instrument Set
1
Pass the leader
Instrument
321.745 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
Instrument
391.905.99 Cable Cutter
Using the Cable Cutter, remove only the tip of the leader.
Separate the cable leaders.
Synthes Spine 5
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
Instrument
321.744 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.
6Synthes Spine Spine Cable System
5
Attach Tensioner/Crimper
Instrument
321.131 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
Instrument
321.132 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.
8Synthes Spine Spine Cable System
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
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.
Technique — Double-Lead Cable continued
10 Synthes Spine Spine Cable System
11
Remove excess cable
Instrument
391.905.99 Cable Cutter
Cut the cables flush with the tip of the crimp sleeves using
the Cable Cutter.
Technique — Single-Lead Cable
1
Pass the leader
Instrument
321.745 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
Instrument
391.905.99 Cable Cutter
Using the Cable Cutter, remove only the tip of the leader.
Synthes Spine 11
Technique — Single-Lead Cable continued
12 Synthes Spine Spine Cable System
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
Instrument
321.131 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.
6
Adjust the torque setting
Instrument
321.132 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
Technique — Single-Lead Cable continued
14 Synthes Spine Spine Cable System
8
Secure the crimp
Secure the crimp by squeezing the handles until they
automatically release. Remove the Tensioner/Crimper.
9
Remove excess cable
Instrument
391.905.99 Cable Cutter
Cut the cable flush with the tip of the crimp sleeve using
the Cable Cutter.
Synthes Spine 15
Instruments
321.745 Cable Retriever
Facilitates sublaminar cable passage
391.905.99 Cable Cutter, standard
Cuts cable flush with head of crimp
321.131 Tensioner/Crimper
Automatically releases when the crimp is
fully secured. Single instrument applies tension
and crimps
321.744 Pretensioner
Holds cable tension prior to crimping
321.132 Torque Limiting Handle
Tension level can be set using the adjustable
Torque Limiting Handle
Spine Cable Instrument Set (105.803)
Graphic Case
690.036 Spine Cable System Instrument Set
Graphic Case
Instruments
321.131 Tensioner/Crimper, 2 ea.
321.132 Torque Limiting Handle
321.744 Pretensioner, 4 ea.
321.745 Cable Retriever
391.905.99 Cable Cutter, standard
Also Available
1.0 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
16 Synthes Spine Spine Cable System
1.0 mm Cable with Crimp, 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
http://us.synthes.com/Medical+Community/Cleaning+and+Sterilization.htm
or to the below listed inserts, which will be included in the shipping container:
—Processing Synthes Reusable Medical Devices—Instruments, Instrument Trays
and Graphic Cases—DJ1305
—Processing Non-sterile Synthes Implants—DJ1304
Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185
© 2001 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
www.synthes.com

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