BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES, USA DRILL BIT 2.0

    MDR report key: 205078 · Received January 6, 1999

    Report

    Report Number
    MW1015371
    Event Type
    Malfunction
    Date Received
    January 6, 1999
    Date of Event
    December 14, 1998
    Report Date
    December 22, 1998
    Manufacturer
    SYNTHES
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER OPEN REDUCTION INTERNAL FIXATION OF PELVIS, X-RAYS WERE TAKEN. X-RAY SHOWS PORTION OF DRILL BIT LODGED IN PELVIS. AT THIS POINT NO PLANS TO REMOVE. DRILL BIT PORTION RETAINED IS 4 1/4" IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES, USA DRILL BIT 2.0 DRILL BIT HTW SYNTHES ABC 7370 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other DRILL.