BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2991214 · Received March 6, 2013

    Report

    Report Number
    0001811755-2013-00456
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE. (B)(4): THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. DEVICE NOT RECEIVED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96318 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1