BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 13557320 · Received February 18, 2022

    Report

    Report Number
    9611253-2022-00009
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 10, 2022
    Report Date
    March 16, 2022
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAME ADVERSE EVENT IN THIS REPORT HAS BEEN REPORTED TO THE FDA SEPARATELY BY THE DISTRIBUTOR, (B)(4) CORPORATION, UNDER REPORT NUMBER 1422375-2022-00002.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [REPORT NO. C220126-02]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT Z95L DEVICE [SERIAL NO. (B)(6)]. THERE WERE NO PROBLEMS OBSERVED DURING MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. B) NAKANISHI CONNECTED THE HANDPIECE TO THE MOTOR AND TRIED TO ROTATE THE MOTOR. HOWEVER, THE HANDPIECE WAS LOCKED AND THE MOTOR DID NOT ROTATE AT ALL. THEREFORE, NAKANISHI WAS NOT ABLE TO CONDUCT TEMPERATURE TESTING OF THE DEVICE. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) OF THE ASSOCIATED DEVICE COMPONENTS WAS CONDUCTED AS FOLLOWS: A) NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INTERNAL PARTS. NAKANISHI OBSERVED THE FOLLOWING: - THE BEARING RETAINER IN THE BALL BEARING ON THE REAR SIDE OF THE CARTRIDGE WAS BROKEN. - THE INTERNAL PARTS WERE SOILED, ABRADED, AND DISCOLORED. B) NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DISASSEMBLED PARTS AND KEPT THEM IN INVESTIGATION REPORT NO. C220126-02. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI DETERMINED THAT THE CAUSE OF THE OVERHEATING OF THE RETURNED DEVICE WAS ABNORMAL RESISTANCE DURING ROTATION DUE TO THE BROKEN BEARING RETAINER. NAKANISHI CONSIDERS THE POSSIBILITY FROM MANY YEARS OF EXPERIENCE THAT THE CAUSE OF THE BROKEN BEARING RETAINER WAS THE INGRESS OF UNDESIRABLE MATERIALS INTO THE BEARING, LEADING TO ABRASION. B) A LACK OF MAINTENANCE CAUSED THE ACCUMULATION OF DEBRIS ON THE INTERNAL PARTS, WHICH CAUSED DEBRIS INGRESS INTO THE BEARING DURING ROTATION. THIS CONTRIBUTED TO THE HANDPIECE OVERHEATING. C) IN ORDER TO PREVENT A RECURRENCE OF THE HANDPIECE OVERHEATING, NAKANISHI TOOK THE FOLLOWING ACTIONS: C.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. C.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO NSK AMERICA AND DIRECTED NSK AMERICA TO REMIND THE USER OF THE IMPORTANCE OF MAINTENANCE, AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 0

    ON (B)(6) 2022, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2022. THE DENTIST WAS PERFORMING A TOOTH EXTRACTION PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(4)). DURING THE PROCEDURE, THE DEVICE OVERHEATED AND THE PATIENT RECEIVED A MINOR BURN INJURY TO THEIR TONGUE. THE INJURY IS REPORTED TO HAVE HEALED NORMALLY WITHOUT ANY NEED FOR ADDITIONAL MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538212 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. Z95L

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other