BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2070690 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01289
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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 QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING TESTING. UPON FURTHER ANALYSIS, THE BEARINGS AND OTHER COMPONENT PARTS WERE DAMAGED. A DAMAGED SPINDLE HOUSING AND WORN BEARINGS WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE FAULTY PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND 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. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE WITHOUT ANY PROCEDURE DELAY; NO ADVERSE EVENT WAS ASSOCIATED WITH THE EVENT.

    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