BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3934164 · Received July 15, 2014

    Report

    Report Number
    0001811755-2014-02515
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN CONFIRMED THE REPORTED EVENT OF HEATING UP AND NOTED THAT THE DRIVESHAFT BEARING WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. THE CUSTOMER LET THE DEVICE COOL FOR THREE TO FOUR MINUTES BEFORE COMPLETING THE PROCEDURE SUCCESSFULLY USING THE SAME DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. THE CUSTOMER LET THE DEVICE COOL FOR THREE TO FOUR MINUTES BEFORE COMPLETING THE PROCEDURE SUCCESSFULLY USING THE SAME DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413701 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1