BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA TWIST DRILL

    MDR report key: 7101617 · Received December 8, 2017

    Report

    Report Number
    2025102-2017-00006
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    August 9, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFF
    PMA / PMN Number
    K943758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED TO EVALUATE.

    Description of Event or Problem · 1

    DURING ORIF OF LEFT TIBIA A BATTERY POWERED HAND DRILL WITH A 1/16 IN 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 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
    880673 BRASSELER USA TWIST DRILL TWIST DRILL GFF BRASSELER U.S.A. MEDICAL, LLC KM166-00-00

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR