BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2042838 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01034
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE COMPLAINANT'S COMPLAINT WAS CONFIRMED; THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE DURING TESTING. WORN BEARINGS, DAMAGED MOTOR AND SPINDLE HOUSING WERE IDENTIFIED AS THE CAUSE OF THE FAILURE. THE FAULTY PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED, CLEANED, LUBED, ADJUSTED 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 PROCEDURE. NO ADVERSE CONSEQUENCE WAS REPORTED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 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