BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2090670 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01297
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE DURING TESTING. UPON DISASSEMBLY OF THE DEVICE, CORROSION DAMAGE WAS NOTED ON THE MOTOR, ROTOR AND DRIVESHAFT. THE PROBABLE CAUSE OF THE FAILURE WAS ATTRIBUTED TO DAMAGED SPINDLE HOUSING, BURNT MOTOR CARTRIDGE PINS, WORN ROTOR AND DRIVESHAFT BEARINGS. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER CORE IMPACTION DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A QUALITY CHECK. THERE WAS NO PT INVOLVEMENT; NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK