BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2941864 · Received February 4, 2013

    Report

    Report Number
    0001811755-2013-00167
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED FAILURE OF OVERHEATING COULD NOT BE DUPLICATED DURING THE DEVICE EVALUATION, DUE TO A TEMPERATURE WARNING ON THE CONSOLE WHICH PREVENTED THE HANDPIECE FROM RUNNING. HOWEVER, DAMAGED BEARINGS WERE DISCOVERED IN THE DEVICE. THE WORN BEARINGS CAN CAUSE OVERHEATING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED, AND IF ADDITIONAL INFORMATION IS RECEIVED AND REQUIRES REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXTRACTION OF A THIRD MOLAR AT THE USER FACILITY, THE DRILL WAS OVERHEATING. 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 THE EXTRACTION OF A THIRD MOLAR AT THE USER FACILITY, THE DRILL WAS OVERHEATING. 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
    46063 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1