BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILLS

    MDR report key: 6986467 · Received October 30, 2017

    Report

    Report Number
    6986467
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    August 9, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC.
    Product Code
    HBE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ORIF OF LEFT TIBIA A BATTERY POWERED HAND DRILL WITH A 1/16" DRILL BIT WAS BEING USED. UPON COMPLETION OF DRILLING IT WAS NOTED THAT THE DISTAL END OF THE DRILL BIT WAS MISSING. X-RAY REVEALED THE FRACTURED DRILL BIT WAS LOCATED IN THE ANTERIOR CORTEX OF THE TIBIAL DIAPHYSIS. THE MISSING PIECE WAS LEFT IN PLACE AFTER THE SURGEON DETERMINED THAT IT WOULD CAUSE MORE HARM TO THE PATIENT TO TRY AND RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768587 TWIST DRILLS DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BRASSELER U.S.A. MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR DRILL BIT WAS BEING USED IN A DRILL DRIVER.| NO OTHER THERAPIES