BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER ULTIMATE SEQUENCE 25MM X5

    MDR report key: 21893483 · Received April 23, 2025

    Report

    Report Number
    8031010-2025-00061
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 31, 2025
    Report Date
    July 4, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN PART HAS NOT BEEN RETRIEVED AND THE TREATMENT HAS BEEN CONCLUDED. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED. THROUGH PROVIDED PICTURES AND BASED ON CUSTOMER STATEMENT, THE INSTRUMENT FROM THE PROTAPER ULTIMATE SEQUENCE 25MM WHICH WOULD HAVE BROKEN IS THE PROTAPER ULTIMATE SLIDER FILE 25MM. BREAKAGE MANIFESTLY OCCURRED AT THE TIP OF THE ACTIVE PART. NO FURTHER ANALYSIS CAN BE MADE BECAUSE THE DAMAGED FILE IS NOT AVAILABLE PHYSICALLY. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1870414). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE (NUMBER OF USES NOT COMMUNICATED), EXCESSIVE WEAR, PATIENT CONDITION AND BEHAVIOR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). IN ADDITION, THERE ARE FURTHER CIRCUMSTANCES ON THE CONDITIONS IN DENTISTRY (USED DISINFECTANTS, TRAINING/KNOWLEDGE STATUS), OR ANY OTHER ENVIRONMENTAL CONDITIONS, WHICH ARE UNKNOWN TO US AND MAY ALSO HAVE AN IMPACT ON THE REPORTED FAILURE MODE. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE - 4580. HEALTH EFFECT - IMPACT CODE - 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 3165. HEALTH EFFECT - IMPACT CODE - 2199. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED A PROTAPER ULTIMATE SEQUENCE 25MM X5 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627760 PROTAPER ULTIMATE SEQUENCE 25MM X5 FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1870414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown