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Verfügbare Sprachen
ADVERSE EVENTS
1.
Infections, both deep and superficial.
2.
Allergies, tissue irritation/inflammation and other reactions to device materials.
INSTRUCTIONS FOR USE
1.
Using the appropriate bone punch or tap, create a pilot hole in the bone in the desired location for the
GENESYS CrossFT Suture Anchor. Make sure to punch or tap until the distal depth mark is just below the
surface of the bone.
2.
If hard bone is encountered, use the bone tap to create a threaded pilot hole.
WARNING: If a bone tap is not used in a hard bone condition it may result in an increased risk of anchor
or driver breakage and unintentional patient injury.
3.
Remove the bone punch or tap from the pilot hole.
4.
Establish axial alignment and insert the anchor into the pilot hole.
5.
Rotate the handle clockwise while applying a small amount of forward pressure with each revolution until the
circumferential laser line on the distal end of the driver is flush with the bone and the laser line is no longer
visible. To ensure the suture slides easily, align one of the vertical laser lines adjacent to the area of soft tissue
where the stitch will be placed.
PRECAUTION: Do not advance driver beyond the circumferential laser line or breakage can occur.
6a. For anchors without needles, release the suture from the disposable driver and withdraw the driver.
6b. For anchors with needles, slide the door back to expose the needles. Using your thumb and one finger,
grasp one set of needles to release. Repeat for the other set of needles. Withdraw the driver.
7.
Apply tension to the suture and test the stability of the GENESYS CrossFT Suture Anchor. Test to see if suture
slides freely through the GENESYS CrossFT Suture Anchor eyelet.
8.
Pass the ends of the suture through the soft tissue and complete the repair.
9.
Cut and remove the excess ends of the suture and/or needles.
10. Repeat the above steps as needed for additional security.
11. Palpate the repair using a probe to ensure that the knots and repair are secure.
PACKAGING, LABELING AND STERILIZATION
1.
The GENESYS CrossFT Suture Anchor should only be used if the original packaging and labeling are intact.
2.
If the GENESYS CrossFT Suture Anchor packaging has been opened or altered, contact your regional
ConMed Linvatec sales representative, or in the U.S. contact the Customer Service Department.
3.
The GENESYS CrossFT Suture Anchor is supplied sterile and is single-use only. Do not resterilize
this device.
CONTACT INFORMATION
For more information or a product demonstration, contact your regional ConMed Linvatec sales representative, or
call1-800-237-0169 in the U.S.
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