BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2123304 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02080
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, NO FAILURES WERE NOTED, THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATION. PREVENTIVE MAINTENANCE WAS DONE, THE DEVICE WAS CLEANED LUBED ADJUSTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT FOR SERVICE DUE TO OVERHEATING DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED.

    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