Adverse Effects - DePuy Mitek HEALIX ADVANCE KNOTLESS Bedienungsanleitung

• Inspect all instruments for damage before use. Do
not attempt to repair.
• A surgeon should not begin clinical use of the
HEALIX ADVANCE KNOTLESS Anchors without
reviewing the Instructions for Use and practicing the
procedure in a skills laboratory.
• Ensure that Anchor is inserted axially to the bone
hole (limit off-axis insertion).
• Ensure area of anchor insertion is free of soft tissue.
• Improper instrument use, axial misalignment or
levering with the anchor upon insertion may result in
anchor fracture or reduced performance.
WARNINGS
• 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 over-tensioning
or poor bone quality may result in anchor pullout.
• Immediate range of motion should be avoided to
allow biological bony/soft tissue healing.
• This device is not approved for screw attachment or
fixation to the posterior elements (pedicles) of the
thoracic or lumbar spine.
• 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.
• This product is for single-use only. It has not been
designed to be re-used/re-sterilized. Reprocessing
may lead to changes in material characteristics such
as deformation and material degradation which may
compromise device performance. Reprocessing
of single use instruments can also cause cross-
contamination leading to patient infection. These
risks may potentially affect patient safety.

ADVERSE EFFECTS

Adverse effects of absorbable implanted devices
include mild inflammatory and foreign body reactions.
MR STATEMENT
The HEALIX ADVANCE KNOTLESS Implant(s) and
Sutures are MR SAFE.
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