BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-FIX/IMPLANTS

    MDR report key: 1810362 · Received August 20, 2010

    Report

    Report Number
    1219602-2010-00217
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANUFACTURE
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING MENISCAL REPAIR, KNOT PUSHER/SUTURE CUTTER WAS TOO SHARP - PREMATURELY CUT SUTURE BEFORE KNOT WAS CINCHED DOWN. SURGEON TRIED PULLING ON SUTURE TO TIGHTEN KNOT, BUT THAT DID NOT WORK. IT WAS CONFIRMED THAT THEY WERE UNABLE TO CINCH DOWN THE SUTURE ON THE FF DEVICE SO THE SURGEON TRIMMED AWAY THE SUTURE AND LEFT THE TS UNSUPPORTED IN THE CAPSULE. AN ADDITIONAL FF WAS USED TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-FIX/IMPLANTS UNKNOWN FAST-FIX GAT SMITH & NEPHEW ENDOSCOPY MANUFACTURE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1