BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 2860031 · Received October 31, 2012

    Report

    Report Number
    1419322-2012-00039
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING THIS DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. MAXIMUM TEMPERATURE EXCEEDED THE ES-1104 TEMPERATURE LIMIT AND FAILED TNS702 PERFORMANCE TESTING. THE ATTACHMENT EXHIBITED A TEMPERATURE INCREASE DURING FREE RUN TESTING OF 64.9 DEGREES CENTIGRADE AND UNDER LOAD OF 74.5 DEGREES CENTIGRADE PER ES-1104. THE CAP END BEARING FAILURE, FREE ROAMING BALL BEARINGS AND EXCESSIVE DEBRIS MOST LIKELY CREATED FRICTION WITHIN THE HEAD WHICH RESULTED IN TEMPERATURE INCREASE. A LACK OF LUBRICATION AND GEAR WEAR WAS ALSO NOTICED. EACH OF THESE FACTORS CONTRIBUTED TO THE OVERHEATING OF THE ATTACHMENT.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT AN ESTYLUS 1:5 HANDPIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1