DePuy Synthes GRYPHON BR Manual De Instrucciones página 2

ENGLISH
GRYPHON™ BR Anchor
CONTENTS
Contents are STERILE unless packaging is damaged
or open.
DESCRIPTION
The GRYPHON BR Anchor is a Composite (PLGA/
TCP) absorbable suture anchor preloaded on a
disposable inserter assembly intended for fixation of
one or two strands of #2 suture to bone. This operative
suture is provided without needles. The implant is
supplied sterile ready to use.
MATERIALS
Handle: ABS
Anchor: Composite made of absorbable Poly
(lactide-coglycolide) polymer and Tricalcium
phosphate (TCP).
Shaft:
Stainless steel
Suture: ORTHOCORD
braided, composite suture composed of dyed
(D&C Violet #2 or D&C Blue #6) absorbable
polydioxanone (PDS
absorbable polyethylene. The partially
absorbable suture is coated with a copolymer
of 90% caprolactone and 10% glycolide.
The PDS copolymer has been shown to be
nonantigenic, nonpyrogenic and elicits only a slight
tissue reaction during absorption.
INDICATIONS
The GRYPHON BR Anchor is intended for:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP
Lesion Repair, Biceps Tenodesis, Acromio-Clavicular
Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization,
Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral
Collateral Ligament Repair, Posterior Oblique Ligament
Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial
Collateral Ligament Reconstruction;
Hip: Capsular repair, acetabular labral repair.
CONTRAINDICATIONS
1. Procedures other than those listed in the
INDICATIONS section.
2. Pathologic conditions of bone such as cystic
changes or severe osteopenia that would impair its
ability to securely fix the GRYPHON BR anchor.
3. Pathologic changes in the soft tissues being fixated
to bone that would prevent their secure fixation by
the GRYPHON BR anchor.
4. Comminuted bone surface that would militate against
secure fixation of the GRYPHON BR anchor.
5. Physical conditions that would eliminate or tend to
eliminate adequate implant support or retard healing,
i.e., blood supply limitation, previous infection, etc.
Suture is a synthetic, sterile,
®
) and un-dyed non-
®
2