Adverse Effects - DePuy Synthes GRYPHON BR Manual De Instrucciones

6. Conditions which tend to limit the patient's ability
to restrict activities or follow directions during the
healing period.
7. The GRYPHON BR anchor is not designed for and
should never be used to attach artificial ligaments.
PRECAUTIONS
1. This product should be used only by physicians
with a thorough understanding of orthopedic
procedures and arthroscopic techniques.
2. The GRYPHON BR anchor is supplied STERILE,
and is intended for single use only. Do not
resterilize. Do not use if sterile packaging appears
to be damaged.
3. The product should be stored under cool, dry
conditions.
4. Inspect all instruments for damage before use.
Do not attempt to repair.
5. A surgeon should not begin clinical use of the
GRYPHON BR anchor without reviewing the
Instructions for Use and practicing the procedure in
a skills laboratory.
6. Axial misalignment or levering with the anchor upon
insertion, may result in anchor or inserter fracture.
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.
5. 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.
Broken needles may result in extended or additional
surgeries or residual foreign bodies. Inadvertent needle
sticks with contaminated surgical needles may result in
the transmission of blood-borne pathogens.
MRI STATEMENT
The GRYPHON™ BR Anchor is MR Safe.
INSTRUCTIONS FOR USE
Push-In Technique – Gryphon-P
1. Through the drill guide, drill a hole in the bone at
the desired location using the GRYPHON drill bit.
3