BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E3 TORQUE CONTROL MOTOR

    MDR report key: 3955724 · Received February 5, 2014

    Report

    Report Number
    9611053-2014-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    EBW
    PMA / PMN Number
    K103653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS LIKELY THAT BECAUSE THE MOTOR WAS NOT RECIPROCATING, THAT THE DOCTOR COMPLETED THE TREATMENT IN ANOTHER MODE, SUCH AS ROTARY MODE. IF RECIPROCATING FILES ARE DRIVEN IN ROTARY MODE THE RISK FOR BREAKAGE IS HIGH BECAUSE THE TORQUE IS NOT CONTROLLED. FURTHER, ROTARY MODE IS IN GENERAL THE WRONG MOVEMENT FOR THE FILE TYPE. HOWEVER, BECAUSE THE EVALUATION OF THE UNIT INVOLVED IS NOT COMPLETE AS OF THIS REPORT AND SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE FILE SEPARATION EVENTS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT AN E3 MOTOR WOULD NOT FUNCTION IN THE RECIPROCATING MODE, POSSIBLY CAUSING TWO FILES TO BREAK. THE DOCTOR WAS ASKED TO CALIBRATE THE UNIT, WHICH HE DID WITHOUT ISSUES. AFTERWARDS, THE MOTOR WAS RECIPROCATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75816 E3 TORQUE CONTROL MOTOR EBW DENTSPLY TULSA DENTAL SPECIALTIES

    Patients

    Seq Age Sex Outcome Treatment
    1