BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDWEST E HIGH SPEED ATTACHMENT 1:5 HS FO CA

    MDR report key: 6137924 · Received December 1, 2016

    Report

    Report Number
    1419322-2016-00301
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EGS
    PMA / PMN Number
    K132356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RETURNED ATTACHMENT WAS TESTED BY MANUFACTURING PERSONNEL AND DID NOT MEET SPECIFICATION. QUALITY PERSONNEL THEN INVESTIGATED THE ATTACHMENT. THE ATTACHMENT MAXIMUM TEMPERATURE WHILE FREE RUNNING WITH COOLANT SPRAY OFF WAS 74.3°C AND 120.3°C UNDER LOAD TESTING WITH COOLANT SPRAY ON. THESE TEMPERATURES DID EXCEED SPECIFICATION. THE ATTACHMENT WAS THEN DISASSEMBLED AND MICROSCOPICALLY EVALUATED. MICROSCOPIC EVALUATION REVEALED MINOR GEAR WEAR. HEAD CAVITY LOOKED DRY WITH ONLY MINOR DEBRIS. DEBRIS WAS NOTED INSIDE THE CAP CAVITY END INNER COMPONENTS. CAP END BEARING RETAINER EXHIBITED SIGNIFICANT WEAR AND IT WAS BROKEN INTO PIECES. THIS FAILURE WOULD HAVE RESULTED IN INSTABILITY OF THE SET ASSEMBLY AND AS A RESULT INCREASE THE TEMPERATURE CAUSING HEAT REPORTED IN THE COMPLAINT.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT A MIDWEST E 1:5 ATTACHMENT OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789167 MIDWEST E HIGH SPEED ATTACHMENT 1:5 HS FO CA HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY PROFESSIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1