BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    MDR report key: 2873477 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01570
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING AN ORIF OF THE PELVIS, THE TIP OF THE DRILL BIT BROKE OFF IN THE ACETABULUM. SURGEON CONFIRMED FRAGMENT LOCATION WITH X-RAY. THE TIP REMAINS IN THE BONE AND WILL NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CAL. HTW SYNTHES GMBH 7904942

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR