MalfunctionGAS

FAST-FIX MENISCAL REPAIR SYSTEM, STRAIGHT

Received Jul 15, 2009 · Event occurred Aug 17, 2009

Report 1219602-2009-00246 · MDR key 1503163

Device

Generic name

Fast-fix Meniscal Repair System, Straight / Gas

Manufacturer

Mansfield Manufacturing Site

Model number

7207876

Catalog number

7207876

Lot number

50214713

Product problems

Sticking
Device Issue

Patient

Not reported

Unknown (for use when the patient's condition is not known)

Narrative

Additional Manufacturer Narrative

DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4).

Description of Event or Problem

DURING A MENISCAL REPAIR, THE KNOT DID NOT SLIDE AFTER BOTH T'S WERE PLACED. SUTURES WERE CUT AND T'S REMAIN IN THE PT. A BACK-UP DEVICE WAS AVAILABLE.