BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 1942295 · Received December 22, 2010

    Report

    Report Number
    1811755-2010-02102
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE ROTOR WAS LODGED IN THE MOTOR. THE MOTOR, ROTOR, ALONG WITH OTHER COMPONENTS, WERE REPLACED.

    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 MICRO DRILL POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK