Synthes LUPINE BR Anchor, Manual

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• Comminuted bone surface which would compromise
secure anchor fixation.
• Conditions which would eliminate, or tend to eliminate,
adequate implant support or retard healing, i.e., blood
supply limitation, infection, tend to compromise the
patient’s ability to heal, such as cognitive state; require
prolonged approximation of tissues under stress, such
as when wound healing is expected to be delayed (e.g.,
steroid therapy, chemotherapy.)
• Attachment of artificial ligaments or other implants.
WARNINGS
Because the anchor is absorbable, immobilization by
external support should be employed. The LUPINE
BR Anchor is designed to lock into cancellous bone.
After removing the inserter, apply nominal tension
(approximately 8 lbs.) on the suture lengths to completely
set the anchor. Do not use excessive tension or overload
the suture. Doing so can lead to bone breakage and
subsequent device pullout, or suture breakage.
In the event that a LUPINE BR Anchor must be removed,
overdrill the original insertion hole or use curettes to open
the cortical surface. Carefully remove the cancellous
bone to expose the anchor. Use a needle holder or
forceps to grasp the anchor and remove it.
A LUPINE BR Anchor must never be reused.
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.
In the event the anchor should dislodge from the inserter
or bone site, do not attempt to reattach the anchor to the
inserter. In this case, discard the anchor and inserter, and
use a new anchor. 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. Incomplete insertion or poor bone quality may result
in anchor pullout.
PRECAUTIONS
• A surgeon should not attempt clinical use of the LUPINE
BR Anchor before reviewing instructions for use.
• As with any suture anchor device, care should be taken
to avoid suture damage during insertion. Bony surfaces
which may contact the suture should be smoothed to
avoid nicking.
• Residual bone fragments should be removed from the
drilled hole site because they may interfere with proper
placement or seating of the anchor.
• Proper seating of the device is required for optimal strength.
• 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.
• 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.
• Users should exercise caution when handling surgical
needles to avoid inadvertent needle sticks. Discard
used needles in sharps containers.
• Use this anchor with a drill bit that generates a precise
2.9mm diameter hole of at least 18mm in depth.
• Do not resterilize. After the package has been opened,
discard any unused suture anchor. Resterilization
compromises the integrity of the anchor system and/or
anchor and may lead to serious surgical consequences.
• Use of a drill guide to stabilize the drill may help to
achieve optimal fit.
• If a drill guide is used, maintain the orientation of the
drill guide to the bone while drilling, as well as when
removing the drill bit. This helps ensure alignment of
the anchor to the axis of the hole.
• Do not twist or apply bending force to the inserter.
Doing so may damage the anchor, suture, or inserter tip.
• Excessive tension may overload the anchor or suture.
CONTENTS
Contents are STERILE unless packaging is damaged
or opened.