BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK PD-2SD

    MDR report key: 4805639 · Received May 26, 2015

    Report

    Report Number
    9611253-2015-00074
    Event Type
    Injury
    Date Received
    May 26, 2015
    Report Date
    May 21, 2015
    Manufacturer
    NAKANISHI INC. (NSK)
    Product Code
    HBC
    PMA / PMN Number
    K132264
    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 AND INVESTIGATION ON 06/09/2014. 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 TEMPERATURE OF THE OPERATING DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED: THE DEVICE WAS CONFIGURED FOR TEMPERATURE TESTING IN THE EXACT STATE IN WHICH IT WAS RETURNED. SPECIFICALLY, NO LUBRICATION OR CLEANING WAS PERFORMED ON THE RETURNED DEVICE BEFORE THIS FIRST TEST IN ORDER TO CHARACTERIZE THE DEVICE UNDER CONDITIONS THAT WOULD DUPLICATE THE USE SITUATION AT THE TIME OF THE EVENT. NAKANISHI ROTATED THE MOTOR OF THE RETURNED HANDPIECE AT 60,000 RPM AND MEASURED THE TEMPERATURE. THE TEMPERATURE WAS MEASURED AT TWO TEST POINTS (I.E., ATTACHMENT AND MOTOR) ON THE EXTERIOR OF THE HANDPIECE USING A THERMOMETER. THE AMBIENT ROOM TEMPERATURE WAS ALSO MEASURED AS REFERENCE. THE TEMPERATURE REACHED 42.4 DEGREES C AT THE ATTACHMENT AND 41.4 DEGREES C AT THE MOTOR. NAKANISHI ALSO CONFIRMED THE ABNORMAL NOISE FROM THE ROTATION. NAKANISHI THEN MEASURED THE TEMPERATURE OF THE RETURNED MOTOR (MODEL PD-MH) WITH A NORMAL ATTACHMENT (MODEL PD-2SD), AND OBSERVED NO ABNORMAL TEMPERATURE. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENT(S) INVOLVED: NAKANISHI DISASSEMBLED THE ATTACHMENT AND PERFORMED A VISUAL INSPECTION OF THE INSIDER PARTS. NAKANISHI OBSERVED DEBRIS AND SHAVINGS FROM THE RETAINER. NAKANISHI ALSO OBSERVED THAT THE SECOND BEARING FROM THE TOP HAD BEEN BROKEN AND 2 BALLS IN THE BEARING HAD BEEN WORN. THE USER ADMITTED THAT ANY MAINTENANCE HAD NOT BEEN CONDUCTED BEFORE THE INCIDENT. CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI IDENTIFIED THAT THE CAUSE OF OVERHEATING OF THE RETURNED DEVICE WAS DUE TO DEBRIS AND SHAVINGS GENERATED BY THE FAILURE OF THE MAINTENANCE. THE DEBRIS AND SHAVINGS OBSERVED CAUSED DAMAGE THAT RESULTED IN ABNORMAL ROTATIONAL RESISTANCE, WHICH WOULD RESULT IN THE HANDPIECE OVERHEATING. NAKANISHI REMINDED THE USER OF THE INSTRUCTION INCLUDED IN THE USER MANUAL.

    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, NAKANISHI IS LIMITED IN THE INFO THAT WE CAN OBTAIN FROM THE INITIAL COMPLAINANT. THE FOLLOWING INFO IS FROM A DIST TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY: ACCORDING TO THE DIST, THE HANDPIECE AND THE MOTOR HEATED UP DURING TREATMENT, AND THE PT WAS BURNED. THE DIST DID NOT MENTION WHICH PARTS THE PT WAS BURNED ON. NAKANISHI COULD NOT OBTAIN INFO WHEN THIS ADVERSE EVENT OCCURRED. COMPLAINT REVIEW: THERE WERE NO PRIOR REPAIRS ON FILE FOR THIS HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340430 NSK PD-2SD HBC NAKANISHI INC. (NSK) PD-2SD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R