BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3925647 · Received July 10, 2014

    Report

    Report Number
    0001811755-2014-02453
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS DUPLICATED. UPON DISASSEMBLY THE DEVICE WAS CONFIRMED TO HAVE BRINELLED DRIVE SHAFT BEARINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. FOLLOWING THE PROCEDURE IT WAS NOTED THAT THERE WERE BLACK BURN MARKS ON THE BUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. FOLLOWING THE PROCEDURE IT WAS NOTED THAT THERE WERE BLACK BURN MARKS ON THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404242 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSTRUMENTS PRODUCTUNKNOWN BUR GUARD| UNKNOWN INSTRUMENTS PRODUCTUNKNOWN BUR