BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3883600 · Received June 19, 2014

    Report

    Report Number
    0001811755-2014-02198
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 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 WAS UNABLE TO DUPLICATE THE REPORTED EVENT BUT NOTED THAT THE DRIVESHAFT BEARING WAS DAMAGED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES ON DIFFERENT DATES AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. UPON FOLLOW UP, THE USER FACILITY COULD NOT PROVIDE EXACT DATES OR AN EXACT NUMBER OF PROCEDURES IN WHICH THE DRILL WAS USED. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MULTIPLE PROCEDURES ON DIFFERENT DATES AT THE USER FACILITY, THE CORE IMPACTION DRILL WAS OVERHEATING. UPON FOLLOW UP, THE USER FACILITY COULD NOT PROVIDE EXACT DATES OR AN EXACT NUMBER OF PROCEDURES IN WHICH THE DRILL WAS USED. THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITH NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359819 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1