BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM DRILL BIT W/STOP

    MDR report key: 52414 · Received November 19, 1996

    Report

    Report Number
    1719045-1996-00009
    Event Type
    Other
    Date Received
    November 19, 1996
    Date of Event
    September 24, 1996
    Report Date
    October 14, 1996
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1.1MM X 4MM DRIL BIT BROKE OFF IN THE SKULL WHILE DRILLING HOLES FOR PLATE ON CRANIOTOMY. MAXIOFACIAL ASIF SET USED. APPROX 1MM OF THE END OF THE DRILL BIT WAS LEFT IN THE SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1MM DRILL BIT W/STOP Implant DRILL BIT HTW SYNTHES USA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other