BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST TRADITION PB FIBER OPTIC

    MDR report key: 6194359 · Received December 21, 2016

    Report

    Report Number
    1419322-2016-00320
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    December 21, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K963050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 INVESTIGATION COULD NOT SUPPORT THE REPORTED COMPLAINT. THE RETURNED HANDPIECE WAS TESTED BY MANUFACTURING PERSONNEL AND DID MET ALL SPECIFICATIONS CRITERIA. QUALITY PERSONNEL THEN INVESTIGATED THE HANDPIECE. THE HANDPIECE EXHIBITED MAXIMUM TEMPERATURE OF 20.9°C DURING FREE RUN TESTING AND 15.8°C DURING LOAD TESTING. PER ISO 13732-1, THESE TEMPERATURE LEVELS DO NOT REACH THE BURN THRESHOLD REGARDLESS OF THE CONTACT PERIOD. MICROSCOPIC EVALUATION REVEALED DEBRIS WITHIN THE CAP AND HEAD CAVITIES AND CAP END BEARING OUTER RACE. MICROSCOPIC EVALUATION REVEALED SIGNIFICANT WEAR ON THE INSIDE SURFACE OF THE CAP BUTTON THAT FACES THE PUSHER AND ON THE PUSHER ITSELF. THIS INDICATES SEVERE INTERACTION BETWEEN THESE TWO MECHANISMS AT HIGH ROTATIONAL SPEEDS WHICH MOST LIKELY CREATES HEAT NOTED IN THE COMPLAINT.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A TRADITION HANDPIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842772 MIDWEST TRADITION PB FIBER OPTIC HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1