BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST STYLUS MINI 540S (STANDARD)

    MDR report key: 5446483 · Received February 19, 2016

    Report

    Report Number
    1419322-2016-00024
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Report Date
    January 19, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EFB
    PMA / PMN Number
    K003518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 RETURNED HANDPIECE WAS TESTED BY MANUFACTURING PERSONNEL AND DID NOT MEET PRODUCTION SPECIFICATIONS FOR NOISE AND CUT PERFORMANCE. QUALITY PERSONNEL THEN INVESTIGATED THE HANDPIECE. THE MAXIMUM RECORDED TEMPERATURE OF THE HANDPIECE WHILE FREE RUNNING WAS 22.8 C AND 16.5 C UNDER LOAD TESTING. PER ISO 13732-1, THIS TEMPERATURES LEVEL DOES NOT QUALIFY AS A BURN REGARDLESS OF THE CONTACT PERIOD. IT WAS NOTED THE CUT QUALITY WAS POOR DURING TESTING WHICH SUPPORTED PRODUCTION FINDINGS RECORDED IN THE NWA RESULTS. THE HANDPIECE EXHIBITED EVIDENCE OF THE SET COMING INTO CONTACT WITH THE INTERIOR OF THE CAP CAVITY DURING USE. THE CAP END BEARING ASSEMBLY WAS ALSO FOUND LODGED IN THE CAP CAVITY. THIS FRICTION DURING USE IN THE FIELD WAS THE MOST LIKELY CAUSE FOR THE CUSTOMER COMPLAINT. ALL COMPONENTS LOOKED DRY WITH NO EVIDENCE OF LUBRICATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103171 MIDWEST STYLUS MINI 540S (STANDARD) HANDPIECE, AIR-POWERED, DENTAL EFB DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1