BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK X-SL

    MDR report key: 4740207 · Received April 28, 2015

    Report

    Report Number
    9611253-2015-00059
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 15, 2013
    Report Date
    April 20, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (C130326-03-1). THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORDS FOR THE SUBJECT X-SL (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISH 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 (B)(4). NAKANISHI'S ACCEPTANCE CRITERIA FOR THE BUR DETACHMENT FORCE IS (B)(4) OR ABOVE, INDICATING THAT THE BUR DETACHMENT FORCE OF THE SUBJECT HANDPIECE HAD NOT DETERIORATED. NAKANISHI MEASURED BUR RETENTION TORQUE AND CONFIRMED IT WAS (B)(4). NAKANISHI'S ACCEPTANCE CRITERIA FOR THE BUR RETENTION FORCE IS (B)(4) OR ABOVE, INDICATING THAT THE BUR RETENTION TORQUE HAD DETERIORATED. NAKANISHI CONDUCTED CUTTING TESTING BY USING THE RETURNED HANDPIECE, A BUR EQUIVALENT TO THE ONE SWALLOWED BY THE PT (MANI CARBIDE BUR 1970) AND A SIMULATED SUBJECT (BRASS TEST PIECE). IT WAS CONFIRMED THAT THE BUR WAS GRADUALLY SLIDING OUT OF THE CHUCK DUE TO THE CUTTING LOAD. NAKANISH DISASSEMBLED THE HANDPIECE TO OBSERVE THE INSIDE OF THE CHUCK, COMPARED TO AN UNUSED NEW CHUCK AND TOOK PHOTOGRAPHS. NAKANISHI OBSERVED THE RETENTION SURFACE OF THE CHUCK HAD WORN. CONCLUSION REACHED: THE BUR WAS DETACHED FROM THE HANDPIECE DUE TO THE DETERIORATION OF THE BUR RETENTION TORQUE THAT WAS CAUSED BY THE WORN 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. THIS EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE UNITED STATES UNDER K962543.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF OUR INTERNAL REVIEW OF PST 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 THIS DENTIST, A BUR WAS DETACHED FROM A HANDPIECE DURING A TREATMENT AND THE PT ACCIDENTALLY SWALLOWED THE BUR. THIS PT VISITED A HOSPITAL AND THE BUR WAS OBSERVED IN THE STOMACH BY AN X-RAY EXAMINATION. ACCORDING TO THE INFO OBTAINED BY THE DISTRIBUTOR, THE DOCTOR APPLIED LOCAL ANESTHESIA AND TOOK OUT A BUR WITH AN ENDOSCOPE. THE PT DID NOT EXPERIENCE ANY SIGNIFICANT PHYSICAL ISSUES. COMPLAINT REVIEW: THERE IS NO COMPLAINT REVIEW FOR THIS HANDPIECE. INVESTIGATION: THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER (NAKANISHI) FOR AN ANALYSIS AND INVESTIGATION ON 03/20/2013. AS OF THIS REPORT NO ADDITIONAL INFO HAS BEEN RECEIVED. THIS EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS AS MARKETED IN THE UNITED STATES UNDER K962543.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277314 NSK X-SL HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI, INC. (NSK) X-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other