BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BA102

    MDR report key: 5537586 · Received March 31, 2016

    Report

    Report Number
    9611253-2016-00011
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    January 27, 2016
    Report Date
    March 30, 2017
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NAKANISHI CONTACTED THE DISTRIBUTOR TO OBTAIN THE PATIENT INFORMATION BY E-MAIL ON MARCH 14, 2016 AND MARCH 23, 2016, HOWEVER NAKANISHI HAS STILL NOT RECEIVED THE INFORMATION. THIS EVENT OCCURRED IN (B)(6), BUT THE SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K962540.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT FROM A DISTRIBUTOR OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT BA102 DEVICE [SERIAL NUMBER (B)(4)]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. NAKANISHI OBSERVED: A THREAD MISSING FROM THE CONVERTING SCREW DUE TO FRACTURE. THE MISSING THREAD WAS FOUND IN THE SCREW SHAFT. A DUCTILE FRACTURE ON THE FRACTURED SURFACE OF THE CONVERTING SCREW, WHICH INDICATES THAT STRESS OF AN INTENSITY EXCEEDING THE PART TOUGHNESS WAS APPLIED. CORROSION ALL OVER THE CONVERTING SCREW. NAKANISHI TOOK PHOTOGRAPHS OF ALL OF WHAT NAKANISHI OBSERVED AND KEPT THEM IN A FILE. NAKANISHI APPLIED VARIOUS TYPE OF STRESS TO THREE NEW CONVERTING SCREWS TO SEE THE TORQUE WITH WHICH THE THREADS WOULD FRACTURE. NAKANISHI CONFIRMED THE THREADS HAD FRACTURED AT 19N?ECM OR 20N?ECM. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI IDENTIFIED FROM THE ABOVE OBSERVATION THAT THE CAUSE OF CONVERTING SCREW FRACTURE WAS EXCESSIVE STRESS APPLIED DURING CUTTING. IN ORDER TO PREVENT A RECURRENCE OF THE FRACTURE, NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO WARN THE USER NOT TO USE THE DEVICE UNDER HIGH STRESS.

    Additional Manufacturer Narrative · 1

    NAKANISHI SENT TWO EMAIL MESSAGES TO (B)(6) ON APRIL 1, 2016 AND APRIL 29, 2016 TO REQUEST PATIENT'S INFORMATION THAT WAS MISSING IN THE INITIAL REPORT.NAKANISHI RECEIVED AN EMAIL MESSAGE FROM (B)(6) ON MAY 3, 2016 THAT STATES (B)(6) HAD NO PATIENT INFORMATION.

    Description of Event or Problem · 1

    ON MARCH 7, 2016, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT AN NSK DENTAL PRODUCT. DETAILS ARE AS FOLLOWS. ON (B)(6) 2016, A DENTIST WAS POLISHING A PATIENT'S TOOTH USING BA 102 WITH A RUBBER CUP. DURING THE PROCEDURE, THE RUBBER CUP SUDDENLY SNAPPED OFF. ACCORDING TO THE DENTIST, THE PATIENT WAS NOT INJURED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195838 BA102 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. BA102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other