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Parcus PEEK CF Interference Screw
1.
Indications:
The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring
ligament or tendon repair.
2. Contraindications:
A. Any active infection.
B. Blood supply limitations or other systemic conditions that may retard healing.
C. Foreign body sensitivity, if suspected, should be identified and precautions observed.
D. Insufficient quality or quantity of bone.
E. Patient's inability or unwillingness to follow surgeon's prescribed post-operative regimen.
F. Any situation that would compromise the ability of the user to follow the directions for use or using the device for an
indication other than those listed.
3. Adverse Effects:
A. Infection, both deep and superficial.
B. Allergies and other reactions to device materials.
C. Risks due to anesthesia.
4. Warnings:
A. This product is intended for use by or on the order of a physician.
B. The fixation provided by this device should be protected until healing is complete. Failure to follow the postoperative
regimen prescribed by the surgeon could result in the failure of the device and compromised results.
C. Size selection of the implant should be made with care taking into consideration the quality of the bone into which the
implant is to be placed.
D. Any decision to remove the device should take into consideration the potential risk of a second surgical procedure.
Adequate postoperative management should be followed after implant removal.
E. Pre-operative planning and evaluation, surgical approaches and technique, and familiarity of the implant, including its
instrumentation and limitations are necessary components in achieving a good surgical result.
F. This device must never be reused. Reuse or re-sterilization may lead to changes in material characteristics such as
deformation and material degradation which may compromise device performance. Reprocessing of single use
devices can also cause cross-contamination leading to patient infection.
G. This device must never be re-sterilized.
H. Appropriate instrumentation should be used to implant this device.
I.
This device has not been evaluated for safety and compatibility in the MR environment. This device has not been
tested for heating or migration in the MR environment. Use of MR technology in the presence of devices of this
nature may cause magnetically induced displacement forces and torques, radio frequency heating and image
artifacts. Standard MRI screening guidelines for post-operative patients should be followed.
5. Packaging and Labeling:
A. Do not use this product if the packaging or labeling has been damaged, shows signs of exposure to moisture or
extreme temperature or has been altered in any way.
B. Please contact Parcus Medical Customer Service to report any package damage or alterations.
6. Material Specifications:
The Parcus PEEK CF Interference Screw material is Carbon Fiber Reinforced Polyetheretherketone.
7. Sterilization:
This Parcus PEEK CF Interference Screw is supplied sterile.
8. Storage:
Products must be stored in the original unopened package in a dry place and must not be used beyond the expiration
date indicated on the package.
9. Directions for Use:
A. Prepare bone tunnels or sockets using the user preferred technique.
B. Position the graft as desired.
C. Insert the Parcus 1.5mm Guide Wire, in such a manner that the guide wire is interposed between the graft and the
bony wall of the tunnel or socket.
D. Select a screw of the appropriate diameter and length to achieve the desired fixation.
E. Engage the screw onto the Parcus PEEK CF Interference Screw Driver and place the assembly on the guide wire.
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