Johnson & Johnson DePuy Mitek Micro QUICKANCHOR Plus Handbuch Seite 5

PRECAUTIONS
1. A surgeon should not attempt clinical use of the Micro
Anchor before reviewing the instructions for use.
2. As with any suture anchor device, care should be
taken to avoid suture damage during insertion. Bony
surfaces that may contact the suture should be
smoothed to avoid nicking.
3. Residual bone fragments should be removed from
the drilled hole site because they may interfere with
proper placement or seating of the anchor.
4. Proper seating of the device is required for
optimal strength.
5. In handling this or any other suture material, care
should be taken to avoid damage from handling.
Avoid crushing or crimping damage due to
application of surgical instruments such as forceps or
needle holders.
6. As with any suture material, adequate knot security
requires use of accepted surgical techniques for flat
and square ties with additional throws as warranted
by surgical circumstance and the experience of
the surgeon.
7. To avoid damaging needle points and swage areas,
grasp the needle in an area 1/3 to 1/2 of the distance
from the swaged end to the point. Reshaping
needles may cause them to lose strength and be less
resistant to bending and breaking.
8. Users should exercise caution when handling surgical
needles to avoid inadvertent needle sticks. Discard
used needles in sharps containers.
Magnetic Resonance Imaging (MRI) Information
Non-clinical testing has demonstrated that DePuy
Mitek Metal Implants are MR Conditional. A patient
with a metallic implant can be scanned safely under the
following conditions.
3.0 Tesla Systems:
• Static magnetic field of 3.0 Tesla.
• Highest spatial gradient magnetic field of
720 Gauss/cm or less.
MRI Related Heating
• Maximum MR system reported, whole-body-
averaged specific absorption rate (SAR) of 2.9 W/kg
for 15 minutes of scanning (i.e., per pulse sequence).
MRI related heating was assessed for the representative
configurations of the Mitek metal implants following
guidelines provided in ASTM F2182-02a. A maximum
temperature change equal to or less than 2.0 º C was
observed during testing (parameters listed below).
Parameters:
• Maximum MR system-reported, whole-body-
averaged SAR of 2.9 W/kg
• 15-minute duration MR scanning (i.e., per pulse
sequence).
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