BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.5 DRILLBIT

    MDR report key: 2653634 · Received July 2, 2009

    Report

    Report Number
    2653634
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    May 22, 2009
    Report Date
    May 28, 2009
    Manufacturer
    SYNTHES INC
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SCREW WAS ATTEMPTED TO BE PLACED INDEPENDENT OF THE PLATE FROM THE FIRST METATARSAL TO THE MEDIAL CUNEIFORM; HOWEVER, THE DRILL BIT STRUCK A PREVIOUSLY PLACED SCREW AND BROKE OFF WITHIN THE BONE. THIS WAS BURIED DEEP WITHIN THE BONE AND IT WAS DECIDED NOT TO ATTEMPT TO REMOVE THE BROKEN DRILL BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5 DRILLBIT DRILLBIT HTW SYNTHES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR