BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI CANNULATED SCREW SHORT THREAD/48MM

    MDR report key: 1867114 · Received October 8, 2010

    Report

    Report Number
    1719045-2010-00289
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K963192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. INCIDENT OCCURRED INTRAOPERATIVE. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MFR DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO FIX A BIG TOE FRACTURE, THE THREADS OF TWO 4.0MM TI CANNULATED SCREWS (#407.640 AND #407.648) PEELED. SURGEON INDICATED, HE PRE-DRILLED THE HOLES AND NO K-WIRE WAS BEING USED. AFTER PLACING THE SCREWS, FLUORO SHOWED THE FRAGMENTS. SURGEON THEN REMOVED THE SCREWS AND AS MUCH OF THE THREADS AS HE COULD, LEAVING THE REST IN THE PT AND INSERTED TWO NEW SCREWS SUCCESSFULLY TO COMPLETE THE PROCEDURE. THIS REPORT IS #2 OF 2 FOR THE SAME INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI CANNULATED SCREW SHORT THREAD/48MM CANNULATED SCREWS HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI