Adverse Effects - DePuy Mitek HEALIX TRANSTEND Bedienungsanleitung

7. This anchor is not designed for and should never
be used to attach artificial ligaments.
PRECAUTIONS
1. This anchor is supplied STERILE, and is intended
for single use only. Do not resterilize. Do not use
if sterile packaging appears to be damaged. This
product has not been designed to be re­used/
re­sterilized. Reprocessing may lead to changes in
material characteristics such as deformation and
material degradation which may impact the strength
of the device and compromise device performance.
Reprocessing of single use devices can also cause
cross­contamination leading to patient infection.
These risks may potentially affect patient safety.
2. The product should be stored under cool, dry
conditions.
3. Inspect all instruments for damage before use.
Do not attempt to repair.
4. Discard if open but unused. Do not use after
expiration date.
5. A surgeon should not begin clinical use of this
anchor without reviewing the Instructions for Use
and practicing the procedure in a skills laboratory.
6. Inserting the awl/tap or drill bit less than the
specified depth, axial misalignment or levering with
the anchor upon insertion may result in anchor
fracture.
7. Do not apply a bending force to the inserter. This
can damage the anchor or inserter tip.
WARNINGS
1. DePuy Mitek anchors are designed to lock into
cortical or cancellous bone. Bone stock must
be adequate to allow proper and secure anchor
placement. Incomplete insertion or poor bone
quality may result in anchor pullout.
2. Immediate range of motion should be avoided to
allow biological bony/soft tissue healing.
3. This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
4. Users should be familiar with surgical procedures
and techniques involving absorbable and non­
absorbable suture before employing ORTHOCORD
suture for wound closure, as risk of wound
dehiscence may vary with the site of application
and the suture material used.

ADVERSE EFFECTS

Adverse effects of absorbable implanted devices
include mild inflammatory and foreign body reactions.
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