BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES 1.8 DRILL BIT

    MDR report key: 3099627 · Received May 2, 2013

    Report

    Report Number
    MW5030071
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES, INC
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE REPAIRING RIGHT TALUS BONE FRACTURE THROUGH OPEN REDUCTION EXTERNAL FIXATION PROCEDURE, THE 1.8 SYNTHES DRILL BIT BROKE DURING PROCEDURE. THE PHYSICIAN ATTEMPTED TO REMOVE, BUT WAS UNABLE TO REMOVE THE BROKEN PIECE OF THE BIT. THE PHYSICIAN DID NOT FEEL THAT THIS WOULD HARM THE PT. THERE DOES NOT APPEAR TO BE AN EFFECTS OR FURTHER INJURY TO THE PT DUE TO BROKEN DRILL BIT REMAINING IN THE PT'S BONE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193125 SYNTHES 1.8 DRILL BIT SYNTHES 1.8 DRILL BIT HTW SYNTHES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR