BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2033731 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00912
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING QUALITY TESTING. FURTHER INVESTIGATION REVEALED A BROKEN ROTOR AND CORE DRIVE SHAFT. CORROSION DAMAGE TO THE MOTOR CARTRIDGE WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE FAILURE. THE DAMAGED 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 CALLED 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 BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK