BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BA105

    MDR report key: 5528664 · Received March 28, 2016

    Report

    Report Number
    9611253-2016-00012
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    January 21, 2016
    Report Date
    October 7, 2016
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(4), BUT THE SIMILAR PRODUCTS ARE MARKETED IN THE U.S. UNDER K962540.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE: METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT BA105 DEVICE (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. B) NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED A SIMPLE MOVEMENT TEST. C) ROTATION CHECK - NAKANISHI OPERATED THE MOTOR 40,000RPM AND CHECKED THE ROTATION. NAKANISHI COULD NOT FIND ANY ABNORMAL SOUND OR ABNORMAL VIBRATION. D) CHUCK PART CHECK - NAKANISHI REMOVED THE HEAD CAP AND OBSERVED THE CHUCK PART. NAKANISHI COULD NOT DISCERN ANY DAMAGE THAT COULD HAVE LEAD TO CHUCK PART FAILURE. - WHEN NAKANISHI MOUNTED A BUR, NAKANISHI CONFIRMED THAT THE BUR WAS CHUCKED NORMALLY. (NAKANISHI TRIED TO PULL OUT THE BUR WITH FINGERS, BUT WAS UNABLE TO DO SO.) - COMPARING THE BUR INSERTION IN THE RETURNED HANDPIECE TO A NEW HANDPIECE, NAKANISHI COULD NOT FIND ANY DIFFERENCE IN THE CHUCKING STATE. E) BUR RETENTION FORCE - NAKANISHI MOUNTED THE BUR INTO THE CHUCK FOLLOWING THE OPERATION MANUAL AND CHECKED THE RETENTION FORCE. - THE CHUCKING FORCE SPECIFICATION IS 45 N, BUT NAKANISHI MEASURED UP TO 95 N OF FORCE; THE BUR STILL COULD NOT BE PULLED OUT. F) NAKANISHI COULD NOT INVESTIGATE THE FALLEN BUR BECAUSE IT WAS NOT RETURNED TO NAKANISHI. ACCORDING TO THE DISTRIBUTOR, THE BUR THAT WAS USED MAY HAVE BEEN A HENRY SCHEIN BUR. THEREFORE, NAKANISHI IS NOT SURE IF THE DIMENSION OF THE BUR SHANK IS COMPLIANT WITH THE ISO STANDARD. G) VISUAL INSPECTION OF OTHER PARTS - NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE OTHER PARTS. - NAKANISHI COULD NOT FIND ANY DEFECTIVE PORTION SUCH AS DAMAGE OR ABNORMAL WEAR. H) LABELING REVIEW - NAKANISHI CONFIRMED THAT THE OPERATION MANUAL CONTAINS THE FOLLOWING VERBIAGE : "CAUTION: BEFORE USE, MAKE SURE THAT A BUR IS SECURELY LOCKED, PULLING IT GENTLY WITH FINGERS. MAKE A TRIAL RUN" I) CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULT - NAKANISHI COULD NOT FIND ANY ABNORMAL PARTS DURING THE ABOVE INVESTIGATION. NAKANISHI DETERMINED THAT THE RETURNED PRODUCT WAS NORMAL. - NAKANISHI CONFIRMED THROUGH THE INVESTIGATION THAT THE SUFFICIENT RETENTION FORCE CAN BE OBTAINED IF A BUR THAT IS COMPLIANT WITH THE ISO STANDARD IS CHUCKED NORMALLY. NAKANISHI DETERMINED THAT A BUR CAN NOT BE PULLED OUT DUE TO THE USAGE LOAD. - NAKANISHI CONCLUDED THAT THE BUR HAD BEEN PULLED OUT DUE TO DRILLING LOAD WHEN THE BUR WAS NOT CHUCKED CORRECTLY.

    Description of Event or Problem · 1

    NAKANISHI RECEIVED AN EMAIL FROM (B)(6) ON MARCH 7, 2016 THAT STATES THE DENTIST WAS PERFORMING A TOOTH RESTORATION ON A PATIENT WHEN THE BUR FELL OUT OF THE HANDPIECE MID-TREATMENT. THE BUR WAS RETRIEVED FROM THE PATIENT'S MOUTH BY THE DENTIST AND THE PATIENT WAS NOT HURT AT ALL. ACCORDING TO (B)(6), THE BUR BEING USED WAS POSSIBLY A HENRY SCHEIN BUR ROUND STEEL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186577 BA105 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. BA105

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other