BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT

    MDR report key: 6079204 · Received November 4, 2016

    Report

    Report Number
    1419322-2016-00275
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Report Date
    October 5, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 PRODUCTION AND QUALITY TESTING. MAXIMUM TEMPERATURE RECORDED ON THE HEAD OF THE ATTACHMENT DURING FREE RUN TESTING DID EXCEEDED MAXIMUM ALLOWABLE TEMPERATURE. THE ATTACHMENT STOPPED WORKING AFTER 24 SECONDS OF FREE RUN TESTING. BOTH BEARINGS FAILURE, FREE ROAMING BALL BEARINGS AND EXCESSIVE DEBRIS MOST LIKELY CREATED FRICTION WITHIN THE HEAD WHICH RESULTED IN TEMPERATURE INCREASE. IT IS REASONABLE TO SUSPECT GEAR FUNCTION WAS COMPROMISED BY THE ADDED DEBRIS INSIDE THE HEAD WHICH IS EVIDENT FROM SIGNIFICANT WEAR ON THE TEETH OF THE GEARS. INNER COMPONENTS APPEARED TO BE DRY.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730477 ESTYLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1