BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT FOR 5.0MM RECON

    MDR report key: 1882958 · Received October 22, 2010

    Report

    Report Number
    1719045-2010-00302
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO NOT PROVIDED ON INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SUBJECT IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. INVESTIGATION IS NOT COMPLETE, NO CONCLUSION CAN BE DRAWN. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A RIGHT SIDE ADOLESCENT LATERAL ENTRY FEMORAL NAILING, THE DRILL BIT BROKE OFF AND WAS LEFT IN THE FEMUR. THE SURGEON PLANS TO REMOVE THE TIP WHEN THE NAIL IS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT FOR 5.0MM RECON DRILL BIT HWE SYNTHES (USA) NA US99067

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR