BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORE IMPACTION DRILL

    MDR report key: 3915166 · Received July 7, 2014

    Report

    Report Number
    0001811755-2014-02406
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE FOR HEAT WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY, AND VISUAL INSPECTION. THROUGH VISUAL INSPECTION THE TECHNICIAN CONFIRMED THE COUPLER, SOCKETS, AND BEARINGS WERE WORN AND CORRODED. THE DEVICE WAS REPAIRED AND PLACED BACK INTO STRYKER STOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE LOANER CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393425 LOANER CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1