BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2033710 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00919
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION TESTING THE CUSTOMER'S CONCERN WAS CONFIRMED; THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE. FURTHER INVESTIGATION REVEALED A BROKEN ROTOR AND DRIVE SHAFT. CORROSION DAMAGE TO THE MOTOR WAS NOTED AS THE PRIMARY CAUSE OF THE FAILURE. THE PARTS WERE REPLACED AND PREVENTIVE MAINTENANCE WAS DONE. THE DEVICE WAS 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 PROCEDURE. NO ADVERSE CONSEQUENCE WAS REPORTED; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK