BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 4963728 · Received July 29, 2015

    Report

    Report Number
    1419322-2015-00074
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 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. THE COMPLAINT WAS VERIFIED. MAXIMUM TEMPERATURE EXCEEDED THE TEMPERATURE LIMIT. THE ATTACHMENT EXHIBITED TEMPERATURE INCREASE DURING FREE RUN TESTING 39.1 DEGREE CELSIUS AND LOAD TESTING OF 46.5 CELSIUS. THE EXTERIOR OF THE ATTACHMENT DID NOT SHOW ANY MAJOR WEAR. MICROSCOPIC EVALUATION REVEALED MODERATE GEAR WEAR ON THE HEAD-TAIL AND HEAD ASSEMBLIES AND DETACHMENT AND SUBSEQUENT LODGING OF THE CAP END BEARING IN THE CAP CAVITY. THIS WOULD HAVE LED TO SET INSTABILITY, CONTRIBUTING TO THE OVERHEATING SEEN DURING THE INVESTIGATION. THE INTERIOR OF THE HEAD CAVITY AND GEARS WERE DRY AND DID NOT SHOW SIGNS OF LUBRICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS 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
    492349 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1