BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNOT PUSHER/SUTURE CUTTER

    MDR report key: 1810345 · Received August 20, 2010

    Report

    Report Number
    1219602-2010-00216
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 30, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    NBH
    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. TRIED PULLING ON SUTURE TO TIGHTEN KNOT, BUT THAT DID NOT WORK. ADDITIONAL INFORMATION CONFIRMED THAT THEY WERE UNABLE TO TIE OFF THE SUTURE SO THE SURGEON TRIMMED AS MUCH AS POSSIBLE FROM THE FAST-FIX AND THE ANCHORS WERE LEFT IN THE PATIENT UNSUPPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNOT PUSHER/SUTURE CUTTER ULTR FST-FIX KNT PSHER/SUTUR CUTT STRT NBH SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 72201537 50325333

    Patients

    Seq Age Sex Outcome Treatment
    1