Integra Distraction Screws Instructions for Use Rev B.pdf
Integra™ Distraction Screws
INDICATIONS FOR USE
Integra™ Distraction Screws are used in conjunction with orthopaedic
retractors (distractors) for retraction of vertebral bodies during surgical
Integra Distraction Screws are provided either sterile or non-sterile and
are for single use only. The Distraction Screws are available in 12mm,
14mm and 16mm lengths. The proper surgical technique for the use of
Distraction Screws is the responsibility of the surgeon.
Integra Distraction Screws should not be used for anything other than
their intended use.
• Sterility is not guaranteed for sterile product, if package is opened or
• Do not reuse products. Distraction Screws are for single use only.
• Excessive torque may cause screws to break.
• Use of inappropriate size of screw may cause damage to vertebral
Integra Distraction Screws are supplied sterile and non-sterile. All
non-sterile Distraction Screws must be sterilized prior to use according
to hospital protocol and the procedures outlined in this document.
Failure to follow these procedures will invalidate the Distraction Screws’
warranty and can cause the Distraction Screws to fail.
INSPECTION OF ALL DISTRACTION SCREWS
All Distraction Screws are carefully inspected before shipment. Because
damage may occur during transit, the Distraction Screws should be
thoroughly inspected upon receipt. All Distraction Screws must be
inspected prior to use.
Handling and Operating Distraction Screws: Distraction Screws should
be handled and operated by personnel completely familiar with their
use, assembly and disassembly. Before a new non-sterile distraction
screw is used it must be decontaminated and sterilized as described
below. Inspect each Distraction Screw prior to use. Failure to make
a complete inspection to assure the proper operation and function
of the Distraction Screws may result in unsatisfactory performance.
Do not use if the Distraction Screw does not appear to be functioning
properly. Use of Distraction Screws for a task other than that for which
it is intended could result in injury to the patient, damaged or broken
Distraction Screws, or one which provides unsatisfactory performance.
Sterilization and Sterility Assurance in Health Care Facilities”,
ANSI/AAMI ST79:2006. AAMI standards recommend that the sterilizer
manufacturer’s written instructions for cycle parameters should also be
followed. Medical device manufacturer’s exposure times to sterilization
temperature may need to be longer than the minimum indicated by the
sterilizer manufacturer but must never be shorter.
INSTRUCTIONS FOR USE
1. CLEANING DISTRACTION SCREWS: Choose a cleaning
solution appropriate for the Distraction Screws and follow
the manufacturer’s instructions for use. The use of neutral pH
detergents is vital to the maintenance of the screws. Contact with
acidic or alkaline solution will remove the screws’ protective barrier
of chromium oxide, often leading to corrosion, pitting, and breakage.
The ideal cleaning agent is nonabrasive, low-foaming and freerinsing. Using a small clean hand-held brush, remove soil from all
surfaces of the screws while fully immersed in the solution. During
manual cleaning, never use steel wool, wire brushes, scalpel blades
or highly abrasive detergent or cleansers. These will damage the
screws’ protective surface.
1. Non-sterile products must be decomtaminated and sterilized prior
to use (see sterilization procedures below).
2. Choose screw size appropriate for patient’s anatomical site. The
screws should be long enough so that they will penetrate cortical
bone on the posterior wall of the vertebral body, but not so long as
to pass through the wall entirely.
3. The Distraction Screws are self-drilling; however, pre-drilling can
be chosen for patients with poor bone quality. Use only drills
appropriate for spinal applications.
4. Use provided screwdriver to insert one screw in the center of each
vertebral body adjacent to the affected site. Insert screw parallel to
the end plates of the vertebral bodies to ensure proper distraction.
Drill guide may be utilized to assure proper placement of Distraction
5. Screws should be inserted completely so the flange at the base of
the posted section is snug with the anterior wall of the vertebral
body. Do not overtighten or damage can occur to the vertebral
2. RINSE: Thoroughly rinse the Distraction Screw by immersing in tap
water and wiping with a clean, soft cloth.
3. FINAL RINSE should be with “treated water”.
Softened or deionized water should be used for the final rinse to
better remove detergents etc.
• Softening water removes calcium and magnesium ions that cause
water to be hard. Iron ions may also be removed by this treatment.
6. Attach appropriate distractor so its arms slide completely over
the posted sections of both distraction screws. Left and right
distractors are available, depending on the side of the exposure site
on the patient.
• Deionization removes ionized salts and particles from the water.
Excessively hard water can spot or stain screws and excessive
chlorine in water can cause pitting of the screws.
7. Ratchet distractor to desired distraction and perform necessary
procedure. Avoid over-distraction of the vertebral bodies.
4. Decontaminate Clean Distraction Screws: Once screws have
been cleaned they must be rendered safe for handling, inspection
and assembly. They may be decontaminated using the steam
sterilization parameters for unwrapped Items, found in this
8. After completion of the intervertebral procedure, release the
distractor by lifting the thumb latch on the ratchet mechanism. Lift
the distractor off of the screws.
9. Remove Distraction Screw with provided screwdriver.
10. Dispose of Distraction Screws according to Hospital and State
Note: Distraction Screws are for single use only.
TERMINAL STERILIZATION FOR NON-STERILE DISTRACTION
Prior to use, all Non-Sterile Distraction Screws must be cleaned and
sterilized. Independent laboratory testing, conducted according to the
F.D.A. (21 CFR PART 58) and Good Laboratory Practice Regulations
(G.L.P.), has validated steam sterilization as an effective process for
reusable instruments. See also, “Comprehensive Guide to Steam
Deionized water is preferred for the final rinse.
5. Visual Inspection: Visually inspect the distraction screw for
cleanliness and to ensure all parts are in proper working order.
Inspection is a vital part of proper care and maintenance. DO NOT
USE damaged distraction screws.
6. Drying: Before the distraction screw is wrapped for sterilization or
storage, it must be thoroughly dry.
PREPARING DISTRACTION SCREWS FOR STERILIZATION
Prepare the Distraction Screw for sterilization using a wrapper, pouch
or rigid sterilization container that is appropriate for the method of
sterilization to be used. The Association for the Advancement of Medical
Instrumentation (AAMI) and individual sterilizer manufacturers, as well
as medical device manufacturers, provide guidance for the proper
preparation of surgical instrument trays for sterilization.
SYMBOLS USED ON LABELING
TERMINAL STEAM STERILIZATION
After following the decontamination recommendations, Integra
Distraction Screws are ready for sterilization. Independent laboratory
testing, conducted according to the F.D.A. (21 CFR PART 58)
and Good Laboratory Practice Regulations (G.L.P.), has validated
steam sterilization as an effective process for Integra reusable
instruments. See also, AAMI Standards and Recommended Practice,
“Comprehensive Guide to Steam Sterilization and Sterility
Assurance in Health Care Facilities”, ANSI/AAMI ST79:2006.
AAMI standards recommend that the sterilizer manufacturer’s written
instructions for minimum cycle parameters should also be followed.
CAUTION: Consult instructions for use
Below are the recommended sterilization parameters:
132° C (270°)
Single Use Only
Federal (USA) law restricts this device to sale by or on the
order of a physician or practitioner
Method of sterilization: ethylene oxide
RETURNED GOODS POLICY
Products must be returned in unopened packages with manufacturer’s
seals intact to be accepted for replacement or credit unless returned
due to a complaint of product defect. Determination of a product defect
will be made by Integra. Products will not be accepted for replacement
if they have been in the possession of the customer for more than 90
PRODUCT INFORMATION DISCLOSURE
INTEGRA AND ITS SUBSIDIARIES (“INTEGRA”) AND MANUFACTURER
EXCLUDE ALL WARRANTIES, EXCEPT INTEGRA’S APPLICABLE
STANDARD WARRANTY WHETHER EXPRESSED OR IMPLIED, INCLUDING
BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. NEITHER INTEGRA
NOR MANUFACTURER SHALL BE LIABLE FOR ANY INCIDENTAL
OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR
INDIRECTLY ARISING FROM USE OF THIS PRODUCT. NEITHER INTEGRA
NOR MANUFACTURER ASSUME NOR AUTHORIZE ANY PERSON TO
ASSUME FOR THEM ANY OTHER OR ADDITIONAL LIABILITY OR
RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.
Integra LifeSciences Corporation
4900 Charlemar Drive, Building A
Cincinnati, OH 45227
Integra and the Integra logo are trademarks of Integra LifeSciences Corporation.
©2011 Integra LifeSciences Corporation. All Rights Reserved.
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