Adverse Events - ConMed CrossFT Manual Del Usuario

ENGLISH/INSTRUCTIONS FOR USE
7. A temporary internal fixation device MUST NEVER BE RE-USED.
8. Do Not Re-sterilize. 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 and threader are single use and must be disposed according to hospital policy and
procedure.
11. Do not load more than the recommended maximum of suture or tape into the CrossFT™ Knotless Biocomposite
Anchor, breakage may result.
12. Ensure the CrossFT™ Knotless Biocomposite Anchor is inserted to the proper depth as denoted by the etch line,
otherwise insufficient fixation or patient injury may result.
13. Do not use suture or tape that is not sold by CONMED because performance cannot be assured.
14. Everyone present in the operating room should wear suitable eye protection.
PRECAUTIONS
1. Federal Law (USA) restricts this device to sale by or on the order of a physician.
2. Ensure proper selection of bone punch, drill bit or tap according to anchor size selection.
3. Inspect all instruments for damage prior to use.
4. Ensure the anchor is properly seated on the driver tip prior to and during implantation.
5. Avoid lateral loading while inserting the suture anchor.
6. Maintain proper alignment during insertion of the anchor and disengagement of the driver. Proper selection and
placement of the implant are important considerations in the successful utilization of this device.
7. Proper orientation and alignment of instruments is important during implantation of the CrossFT™ Knotless
Biocomposite Suture Anchor to minimize possible breakage of the anchor.
Breakage of the CrossFT™ Knotless Biocomposite Suture Anchor is possible if:
a. The bone punch, tap or drill bit is not inserted to the proper depth.
b. The CrossFT™ Knotless Biocomposite Suture Anchor is not properly aligned with the pilot hole.
c. The CrossFT™ Knotless Biocomposite Suture Anchor is loose or not securely attached on the driver.
d. The CrossFT™ Knotless Biocomposite Suture Anchor driver is used for prying.
8. Do not use a CrossFT™ Knotless tap without first creating a pilot hole with an appropriately-sized CrossFT™
Knotless Drill Bit. Bone fracture could result.
9. The CONMED CrossFT™ Knotless Biocomposite Suture Anchor is MR safe.
10. The risk of suture anchor breakage during implantation is reduced by following the specified instructions for use listed
below.
11. Attempting to load 5 or 6 Hi-Fi
suture may result in inability to insert anchor, threader failure and/or inadequate suture fixation.

ADVERSE EVENTS

1. Infections, both deep and superficial.
2. Allergies, tissue irritation/inflammation and other reactions to device materials.
INSTRUCTIONS FOR USE
1. Prepare the insertion site by removing soft tissue from the bone for better visibility.
2. If using as a knotless anchor, follow the following steps. If using the anchor pre-loaded with Hi-Fi
row standard suture anchor, skip to step #3.
#2 suture limbs into the 4.75 mm or 5.5 mm anchor without removing the blue sliding
®
THREADER TAB
DEPTH MARK
KNOTLESS ANCHOR
3
TELESCOPING CLEATS
Tape or as a medial
®
2
STERILIZE