Johnson & Johnson 108805 Manual Download Page 3

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3. Rotator cuff repair
4. Capsule shift repair (glenoid rim)

CONTRAINDICATIONS

• Surgical procedures other than those listed in the INDICA-

TIONS section.

• Pathological conditions of bone such as cystic changes or severe

osteopenia, which would inhibit the drilling of a precise hole or
compromise secure anchor ﬁxation.

• Pathologic conditions in the soft tissue to be attached which would

impair secure ﬁxation by suture.

• 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 Loop 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 Loop Anchor must be removed, over-drill
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 Loop Anchor must never be reused. 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.

As a braided suture, which is essentially absorbed over 1.5 to 2.5 years,
PANACRYL suture may act as a foreign body over an extended period
of time. The surgeon should consider whether use of an absorbable
braided suture is appropriate in speciﬁc situations such as in wounds
that carry an increased risk of infection or contamination.

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 Loop

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 dam-
age 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.