FAST-FIX ASSY REVERSE CURVE

Description of Event or Problem

MALFUNCTION REPORT FORM STATES "SUTURE PULLED OUT WITH EACH OF THE DEVICES DURING USE IN MENISCAL REPAIR. SURGEON DID NOT FEEL SUTURES BREAKING. BACK UP DEVICE WAS USED AND PART OF MENISCUS WAS REMOVED". BOTH T1 AND T2 WERE DEPLOYED. IT DID NOT FEEL LIKE THE KNOTS WERE TIGHTENING LIKE THEY USUALLY DO AND SUTURES EITHER PULLED OUT OR BROKE WHEN KNOT WAS BEING TIGHTENED. SUTURE BROKE AT ABOUT 10CM FROM THE T. ONE T CAME OUT WITH THE SUTURE. WHICH ONE OF THE T'S IS UNK. PARTIAL MENISCECTOMY (PART OF POSTERIOR SEGMENT) WAS PERFORMED AND ANOTHER DEVICE WAS USED TO FINISH THE SURGERY.

Additional Manufacturer Narrative

DEVICE HAS BEEN RETURNED; HOWEVER, EVAL HAS NOT BEEN COMPLETED. (B) (4). (B) (4).