BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 6287898 · Received January 30, 2017

    Report

    Report Number
    9611253-2017-00007
    Event Type
    Injury
    Date Received
    January 30, 2017
    Date of Event
    January 9, 2017
    Report Date
    July 3, 2017
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER E2016004.

    Description of Event or Problem · 0

    ON JANUARY 19, 2017, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ((B)(4)) DESCRIBING A HANDPIECE HEAD CAP HAD COME OFF IN A PATIENT'S MOUTH. DETAILS ARE AS FOLLOWS. ON JANUARY 9, 2017, (B)(4) WAS MADE AWARE OF AN UNCONFIRMED PATIENT INJURY BY AN NSK SALES REPRESENTATIVE; THE (B)(4) SALES REPRESENTATIVE COMMUNICATED BY PHONE THAT A HANDPIECE HEAD CAP CAME LOOSE WHILE THE HANDPIECE WAS IN A PATIENT'S MOUTH; THE NSK SALES REPRESENTATIVE PROVIDED CONTACT INFORMATION FOR THE DENTIST, AND (B)(4) IMMEDIATELY CONTACTED THE DENTIST BY PHONE; THE DENTIST STATED NO PATIENT INJURY OCCURRED AND THE PATIENT SPIT OUT THE HEAD CAP; (B)(4) SENT EMAILS ON JANUARY 9, 2017, JANUARY 10, 2017 AND JANUARY 16, 2017, AND THE (B)(4) PATIENT INFORMATION FORM WAS SENT TO THE DENTIST IN ORDER TO OBTAIN THE PATIENT INFORMATION, BUT THE INFORMATION HAS NOT BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT; THE SUBJECT DEVICE WAS SERVICED AT (B)(4) ON MAY 17, 2016, AND ALL THE TEST VALUES AFTER THE SERVICE WERE WITHIN THE SPECIFICATION ACCORDING TO THE QUALITY INSPECTION TEST RECORDS.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A DISTRIBUTOR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [C170119-02-1]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT Z95L DEVICE [SERIAL NUMBER (B)(4)]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO RECORDS INDICATING NAKANISHI (THE MANUFACTURER) REPAIRED THE DEVICE SINCE THE DEVICE WAS SHIPPED. NAKANISHI RECEIVED THE REPAIR RECORDS FROM NAM, WHICH INCLUDED THE DETAILED INFORMATION ABOUT THE REPAIR NAM CARRIED OUT ALONG WITH THE REPAIR TEST RESULTS THAT INDICATE THE REPAIRED DEVICE PASSED EVERY TEST ITEM. NAKANISHI KEPT THEM IN A FILE. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. OTHER THAN HEADCAP MISSING FROM THE HANDPIECE WHEN THE DEVICE WAS RETURNED, THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS, DENTS OR DEFORMATION, ON THE OUTSIDE OF THE HANDPIECE. NAKANISHI ALSO OBSERVED NO ABRASIONS, DETERIORATION OR DIMENSIONAL ABNORMALITY OF THE HEAD THREAD IN THE VISUAL INSPECTION. NAKANISHI OBSERVED WHETHER OR NOT A HEADCAP OF THE RETURNED HANDPIECE (WITH A NEW HEADCAP ATTACHED) WOULD LOOSEN UNDER THE FOLLOWING CONDITIONS. TIGHTENING TORQUE: 50N?ECM/45N?ECM/35N?ECM/30N?ECM/25N?ECM/20N?ECM/15N?ECM/10N?ECM/ 5N?ECM. BUR: TEST BUR - SHANK: DIA. 1.598MM, LENGTH:19.01MM. CARBIDE BUR 1 (FG-557 PRODUCED BY SS WHITE) - SHANK: DIA. 1.594MM, LENGTH: 19.40MM, WORKING PORTION: DIA. 1.09MM. CARBIDE BUR 2 (FG-1557 PRODUCED BY SS WHITE) - SHANK: DIA. 1.594MM, LENGTH: 19.42MM, WORKING PORTION: DIA. 1.02MM DIAMOND BUR (PRODUCED BY KOMET) - SHANK: DIA. 1.592MM, LENGTH: 19.18MM, WORKING PORTION: DIA. 5.78MM MOTOR ROTATION SPEED: CARBIDE BUR (40,000RPM)/DIAMOND BUR (16,000RPM). LOAD: UNDER NO-LOAD AND UNDER LOAD (LINE ENGRAVING OF PHOSPHOR BRONZE/MELAMINE PLATE). EVALUATION PERIOD: 3 MINUTES FOR EACH EVALUATION UNDER NO-LOAD AND LOAD NAKANISHI DREW A LINE ON THE HEADCAP AND HEAD AND OBSERVED FOR OCCURRENCE OF MISALIGNMENT. THERE WAS NO HEADCAP LOOSENING OBSERVED UNDER ANY CONDITIONS DESCRIBED ABOVE IN THE EVALUATION. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: ALTHOUGH NAKANISHI COULD NOT REPLICATE THE REPORTED EVENT, NAKANISHI CONSIDERS THE POSSIBILITY, FROM SIMILAR PHENOMENON NSK INVESTIGATED IN THE PAST, THAT THE COMBINATION OF A REDUCTION IN HEADCAP TIGHTENING FORCE WITH ABNORMAL VIBRATION (E.G. BUR RUNOUT, CUTTING UNDER HIGH LOAD, ETC.) COULD RESULT IN THE REPORTED HEADCAP LOOSENING/COMING OFF. FAILURE TO CHECK THE HEADCAP TIGHTNESS BEFORE EACH USE AS INSTRUCTED IN THE OPERATION MANUAL, CONTRIBUTES TO THE HEADCAP LOOSENING/COMING OFF WHEN COMBINED WITH ABNORMAL VIBRATION. IN ORDER TO PREVENT A RECURRENCE OF THE HEADCAP LOOSENING/COMING OFF, NAKANISHI TOOK THE FOLLOWING ACTIONS: NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO NSK AMERICA AND DIRECTED NSK AMERICA TO REMIND THE USER OF THE IMPORTANCE OF FOLLOWING INSTRUCTIONS IN THE OPERATION MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68678 NSK HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. Z95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other