BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT

    MDR report key: 6077906 · Received November 3, 2016

    Report

    Report Number
    1419322-2016-00273
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INVOLVING A SIMILAR 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. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH QUALITY TESTING. MAXIMUM TEMPERATURE RECORDED ON THE HEAD OF THE ATTACHMENT EXCEEDED MAXIMUM ALLOWABLE TEMPERATURE. THE ATTACHMENT EXHIBITED A TEMPERATURE INCREASE DURING FREE RUN TESTING OF 61.2°C AND UNDER LOAD OF 67.4°C. MAXIMUM ALLOWABLE TEMPERATURE AT THE TIME OF TESTING WAS 43.2°C. BUR END BEARING RETAINER EXHIBITED CRACK. THIS FAILURE WOULD HAVE LED TO SET INSTABILITY, CONTRIBUTING TO THE OVERHEATING SEEN DURING THE INVESTIGATION. MICROSCOPIC EVALUATION REVEALED MODERATE GEAR WEAR ON HEAD-TAIL AND HEAD ASSEMBLIES. DEBRIS WAS ALSO NOTED WITHIN THE CAP AND BEAD CAVITIES AND INNER COMPONENTS. CORROSION AND LACK OF LUBRICATION WAS ALSO SEEN WITHIN INNER COMPONENTS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727586 ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1