BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST STYLUS ATC HANDPIECE

    MDR report key: 6124853 · Received November 23, 2016

    Report

    Report Number
    1419322-2016-00295
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    October 25, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. BOTH PRODUCTION AND QUALITY PERSONNEL WERE UNABLE TO ACTIVATE THE HANDPIECE. NO RUNNING TEMPERATURE WAS ABLE TO BE RECORDED. POOR LUBRICATION OF THE HANDPIECE MOST LIKELY CAUSED LODGING BALL BEARING DEEP IN THE BALL POCKET AND THE SUBSEQUENT CRACKING OF THE CAP END BEARING RETAINER. DEBRIS WAS NOTED ON SEVERAL INTERNAL COMPONENTS. MOST LIKELY, THIS WAS DUE TO A LACK OF LUBRICATION. IT IS POSSIBLE THAT A LACK OF LUBRICATION COULD CAUSE AN INCREASE IN FRICTION OF THE INTERNAL PARTS. THIS INCREASE IN FRICTION COULD THEN CAUSE AN ACCELERATED WEAR OF THE INTERNAL COMPONENTS RESULTING IN THE DEBRIS NOTED ABOVE. THIS INCREASE IN FRICTION AND DEBRIS BUILDUP COULD HAVE CAUSED THE OVERHEATING AS NOTED IN THE ORIGINAL COMPLAINT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774965 MIDWEST STYLUS ATC HANDPIECE HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1