Smith & Nephew TWINFIX AB Mode D'emploi page 2

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TWINFIX™ AB Preloaded
Suture Anchors
Device Description
Smith & Nephew TWINFIX™ AB Preloaded Suture Anchors
consist of a bioabsorbable suture anchor with attached
non-absorbable suture assembled to an insertion device.
In certain configurations the suture anchor is packaged
with a guide and threaded dilator. The suture anchor is
intended to provide secure reattachment of soft tissue to
bone. Attachment of the soft tissue is performed by the
surgeon's preferred technique.
Contents
The suture anchors are packaged in the following
configurations. Please refer to the box label for specific
size and configuration.
TWINFIX AB Suture Anchor and Threaded Dilator with
Inserter Guide contains:
1 ea. Absorbable suture anchor – poly l-lactide
1 ea. Insertion device – stainless steel shaft with
polycarbonate and ABS handle
1 ea. Guide – polycarbonate or copolyester
1 ea. Threaded dilator – stainless steel shaft with
polycarbonate handle
2 ea. Sutures – braided, silicone or PTFE
impregnated, polyester (USP), non-absorbable
or
braided, uncoated, UHMW polyethylene and
UHMW polyethylene with monofilament
polypropylene cobraid, non-absorbable
TWINFIX AB Suture Anchor contains:
1 ea. Absorbable suture anchor – poly l-lactide
1 ea. Insertion device – stainless steel shaft with
polycarbonate and ABS handle
2 ea. Sutures – braided, silicone or PTFE
impregnated, polyester (USP), non-absorbable
or
braided, uncoated, UHMW polyethylene and
UHMW polyethylene with monofilament
polypropylene cobraid, non-absorbable
Threaded Dilator with Inserter Guide contains:
1 ea. Guide – polycarbonate or copolyester
1 ea. Threaded dilator – stainless steel shaft
with polycarbonate handle
Indications for Use
TWINFIX AB Preloaded Suture Anchors are intended for
use only for the reattachment of soft tissue to bone for
the following indications:
Shoulder
• Bankart lesion repairs
• SLAP lesion repairs
• Acromioclavicular separation repairs
• Rotator cuff tear repairs
• Capsular shift or capsulolabral reconstructions
• Biceps tenodesis
• Deltoid repairs
Foot and Ankle
• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand
• Scapholunate ligament reconstructions
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair
• Biceps tendon reattachment
Knee
• Extra-capsular repairs:
– medial collateral ligament
– lateral collateral ligament
– posterior oblique ligament
• Iliotibial band tenodesis
• Patellar realignment and tendon repairs, including
vastus medialis obliquous advancement
Contraindications
• Known hypersensitivity to the implant material.
Where material sensitivity is suspected, appropriate
tests should be made and sensitivity ruled out prior
to implantation.
• Surgical procedures other than those listed in
the Indications for Use section.
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10600148 Rev. B
TWINFIX™ AB Preloaded
Suture Anchors
Instructions for Use