BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES REPLACEMENT QUICK CONNECT TWIST DRILL ¿ SOLID

    MDR report key: 2840255 · Received May 21, 2012

    Report

    Report Number
    2025102-2012-00003
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    February 2, 2012
    Report Date
    May 21, 2012
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HBE
    PMA / PMN Number
    K984035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVAL, NOR A LOT NUMBER WAS PROVIDED AT THIS POINT.

    Description of Event or Problem · 1

    SURGEON WAS DRILLING BONE TO PLACE A SCREW AND THE DRILL SNAPPED. THE DRILL BIT WAS NOT RETRIEVABLE WITHIN THE BONE, AND WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES REPLACEMENT QUICK CONNECT TWIST DRILL ¿ SOLID TWIST DRILL HBE BRASSELER USA, MEDICAL L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other