BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM PLATE REDUCTION WIRE

    MDR report key: 2111063 · Received May 19, 2011

    Report

    Report Number
    1719045-2011-00254
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A DISTAL RADIUS PROCEDURE, THE 1.25MM PLATE REDUCTION WIRE WAS PUT IN, THEN REMOVED, PLATE ADJUSTED AND WIRE PLACED AGAIN. SURGEON WENT TO REMOVE IT AND PUSHED THE WRONG BUTTON ON THE DRILL AND THE WIRE BROKE. MOST OF THE WIRE WAS REMOVED, THE TIP REMAINS IN THE PT. PROCEDURE WAS COMPLETED WITH AN ADDITIONAL 30 MINS ADDED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.25MM PLATE REDUCTION WIRE 1.25MM PLATE REDUCTION WIRE HRS SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLATE