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Verfügbare Sprachen
Verfügbare Sprachen
WARNINGS
1.
Preoperative and operating procedures, including knowledge of surgical techniques and proper
selection and placement of the implant are important considerations in the successful utilization of this
device. Surgeon must choose proper implant size based on specific procedure and patient history.
2.
Any decision to remove the device should take into consideration the potential risk to the patient of a second
surgical procedure. Implant removal should be followed by adequate postoperative management.
3.
Do not use beyond the expiration date listed on the label. The performance, safety, and/or sterility of the device
cannot be assured beyond the expiration date.
4.
Remove items from the sterile package using aseptic techniques.
5.
Detailed instructions on the use and limitations of the device should be given to the patient. The patient should
be told to follow the surgeon's protocol for postoperative management.
6.
The patient should be advised that product materials may cause allergic reactions including but not limited to,
foreign body reaction, tissue irritation/inflammation or other allergic reactions. Where material sensitivity is
suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.
7.
A temporary internal fixation device MUST NEVER BE RE-USED.
8.
Do Not Resterilize. Single-use only. The ability to effectively clean and re-sterilize this single use
device has not been established and subsequent re-use may adversely affect the performance,
safety, and/or sterility of the device.
9.
In the event that a device is opened and not used, dispose according to hospital policy and procedure.
10. The disposable driver is single use and must be disposed according to hospital policy and procedure.
11. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used
needles in "sharps" container.
PRECAUTIONS
1.
Ensure proper selection of bone punch or tap according to anchor size selection.
2.
Inspect all instruments for damage prior to use.
3.
Ensure the anchor is properly seated on the driver tip prior to and during implantation.
4.
Ensure the free ends of the suture securely fit into the suture retaining mechanism on the driver handle and that
the sliding door is closed (if applicable).
5.
Avoid lateral loading while inserting the GENESYS CrossFT Suture Anchor.
6.
Maintain proper alignment during insertion of the anchor and disengagement of the driver.
7.
For a trans-tissue approach the anchor must be rotated, as opposed to pushed, through the tissue to prevent
tearing.
8.
The risk of Suture Anchor breakage during implantation is reduced by following the specified instructions for use.
9.
Proper selection and placement of the implant are important considerations in the successful utilization of this device.
10. Proper orientation and alignment of instruments is important during implantation of the GENESYS CrossFT
Suture Anchor to minimize possible breakage of the anchor. Breakage of the GENESYS CrossFT Suture
Anchor is possible if:
a. The bone punch or tap is not inserted to the proper depth.
b. The GENESYS CrossFT Suture Anchor is not properly aligned with the pilot hole.
c. The GENESYS CrossFT Suture Anchor is loose or not securely attached on the driver.
d. The GENESYS CrossFT Suture Anchor inserter is used for prying.
e. The GENESYS CrossFT Suture Anchor is advanced too deep.
f. A small amount of forward pressure is not applied while rotating the handle.
11. The GENESYS CrossFT Suture Anchor is MR safe.
12. Federal law restricts this device to sale by or on the order of a physician
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STERILIZE
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