DePuy Mitek Mini Quickanchor Plus Manuel D'instructions page 4

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CONTRAINDICATIONS
1. Reattachment of intracapsular knee ligaments (ACL & PCL).
2. Surgical procedures other than those listed in the
INDICATIONS section.
3. Pathologic conditions of bone, such as cystic
changes or severe osteopenia, which would impair
its ability to securely fix the Depuy Mitek Anchor, are
contraindicated.
4. Pathological changes in the soft tissues sutured to the
bone which would prevent its secure fixation by the
suture are contraindicated.
5. Comminuted bone surface, which would militate
against secure fixation of the Depuy Mitek Anchor, is
contraindicated.
6. Physical conditions that would eliminate or tend to
eliminate adequate implant support or retard healing,
i.e., blood supply limitation, previous infections, etc.
are contraindicated.
7. Conditions which tend to preempt the patient's ability
or the healing period, such as senility, mental illness
or alcoholism are contraindicated.
8. The Depuy Mitek Anchor is not designed for and
should never be used to attach artificial ligaments or
other implants.
WARNING:
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 devices can also
cause cross-contamination leading to patient infection.
These risks may potentially affect patient safety.
PRECAUTIONS
Titanium alloys contain metals which may stimulate
allergic hyper-sensitive responses by the immune system.
The metals used are titanium, aluminum, vanadium and
nickel (Ti, Al, V and Ni). When sensitivity is anticipated,
appropriate pre-operative testing should be conducted. A
surgeon should not attempt clinical use of Depuy Mitek
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