BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2902009 · Received November 26, 2012

    Report

    Report Number
    1811755-2012-04159
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, IT WAS DISCOVERED THAT THE ROTOR ASSEMBLY WAS CORRODED. CORROSION CAN CAUSED INCREASED FRICTION BETWEEN ROTATING COMPONENTS, WHICH CAN CAUSE HEAT TO BE GENERATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING AN ORAL PROCEDURE. THERE WERE NO PT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    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