BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-SU03 GC

    MDR report key: 4805661 · Received May 26, 2015

    Report

    Report Number
    9611253-2015-00066
    Event Type
    Injury
    Date Received
    May 26, 2015
    Report Date
    May 21, 2015
    Manufacturer
    NAKANISHI INC. (NSK)
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER (NAKANISHI) FOR AN ANALYSIS ON (B)(4) 2013. THIS EVENT OCCURRED IN (B)(6) BUT THE SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K113655. UPON RECEIPT FROM THE DENTIST OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE THAT INCLUDED AN ATTEMPT TO MEASURE THE RETENTION FORCE OF THE OPERATING DEVICE ((B)(4)). THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORDS FOR THE SUBJECT TI-SU03 GC (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED A SIMPLE MOVEMENT TEST. THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DEBRIS, ON THE OUTSIDE OF THE HANDPIECE. NAKANISHI MEASURED BUR DETACHMENT FORCE BY SETTING A TEST BUR IN THE HANDPIECE AND CONFIRMED IT WAS 20.9N. NAKANISHI'S ACCEPTANCE CRITERIA FOR THE BUR DETACHMENT FORCE IS 22.0N OR ABOVE, INDICATING THAT THE BUR DETACHMENT FORCE OF THE SUBJECT HANDPIECE HAD DETERIORATED. NAKANISHI DISASSEMBLED THE HANDPIECE TO OBSERVE THE INSIDE OF THE CHUCK, COMPARED TO AN UNUSED NEW CHUCK AND TOOK PHOTOGRAPHS. NAKANISHI OBSERVED THE OBSERVED THE ACCUMULATION OF THE DIRT. CONCLUSION REACHED: THE BUR DETACHED FROM THE HANDPIECE DUE TO THE DETERIORATION OF THE BUR RETENTION TORQUE THAT WAS CAUSED BY THE ACCUMULATION OF THE DIRT INSIDE OF THE CHUCK. NAKANISHI BELIEVES THAT THERE ARE TWO CAUSES FOR THE WEAR OF THE CHUCK: THE HANDPIECE HAD BEEN USED WITH THE DIRT AND DEBRIS INSIDE THE CHUCK. THE HANDPIECE WAS USED UNDER THE LOAD AND ROTATIONAL SPEED THAT WERE HIGHER THAN THOSE SPECIFIED WITH THE RETENTION CAPACITY OF THE CHUCK. NAKANISHI REMINDED THE USER OF THE INSTRUCTION INCLUDED IN THE USER MANUAL IN ORDER TO PREVENT THE DIRT OR DEBRIS ACCUMULATED INSIDE THE CHUCK.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF OUR INTERNAL REVIEW OF PAST COMPLAINTS AND SERVICE RECORDS. DUE TO THE INCIDENT BEING IN THE PAST, WE ARE LIMITED IN THE INFO THAT WE CAN OBTAIN FROM THE INITIAL COMPLAINANT. EVENT SUMMARY: ACCORDING TO THE DENTIST, A BUR DETACHED FROM A HANDPIECE DURING A TREATMENT AND THE BUR WAS STUCK IN THE PATIENT'S GUM. THE DIST DID NOT INFORM NAKANISHI OF THE DETAILED INFO ABOUT THE PT. COMPLAINT REVIEW: THERE WERE NO PREVIOUS REPAIRS ON FILE FOR THIS HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339842 TI-SU03 GC EFB NAKANISHI INC. (NSK) TI-SU03 GC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other