BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 709244 · Received April 19, 2006

    Report

    Report Number
    MW1038749
    Event Type
    Injury
    Date Received
    April 19, 2006
    Date of Event
    March 28, 2006
    Report Date
    April 19, 2006
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CRANIECTOMY WITH RESECTION OF SKULL TUMOR A DRILL BIT "FROZE" AND THE BIT WOULD NOT TURN. THE SCRUB NURSE REMOVED THE ROUTER TO CHECK FOR PLACEMENT AND IT CAME OUT OF THE BIT IN TWO PIECES. WHEN THE BIT FROZE, IT CAUSED A SMALL HOLE IN THE DURA WHICH REQUIRED REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS D-58 TAPERED ROUTER, 1.7MM X 16.0MM HTW STRYKER INSTRUMENTS 5400-71-58 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability