BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SUMEX DRILL

    MDR report key: 1942300 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02104
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK