BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2042841 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01024
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    May 7, 2009
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE COMPLAINANT'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING TESTING. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE WITHIN THE INTERNAL PARTS OF THE DEVICE. THE PRIMARY CAUSE OF THE FAILURE WAS ATTRIBUTED TO THE CORRODED MOTOR. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE MICRO DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK