BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT DRILL BIT

    MDR report key: 96423 · Received May 29, 1997

    Report

    Report Number
    1811755-1997-00047
    Event Type
    Malfunction
    Date Received
    May 29, 1997
    Date of Event
    April 30, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUT DRILL BIT IN U-DRILL, BARELY TOUCHED THE BONE AND FLEW OFF AT SMALLER PORTION THAN SHANK WHICH IS THE CUTTING PART WHICH IS WHERE IT BROKE IN HALF.FLEW ABOUT 1 FT-1 1/2FT. DURING CRANIUM PROCEDURE: NO INJURY TO PT. RUN AT 75K INSTANTANEOUSLY BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT DRILL BIT BUR EJL STRYKER INSTRUMENTS 5110-100-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN