BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER NEXT NITIFILE X1 21MM

    MDR report key: 21321685 · Received February 6, 2025

    Report

    Report Number
    8031010-2025-00015
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. INVESTIGATION RESULTS: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH#: 1831576). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE (MOTOR SETTING NOT COMMUNICATED), EXCESSIVE WEAR, OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PROTAPER NEXT NITIFILE X1 21MM FILE BROKE DURING USE. THE BROKEN PART IS IN THE APICAL THIRD AND CANNOT BE REMOVED. BROKEN PART REMAINS. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247802 PROTAPER NEXT NITIFILE X1 21MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1831576

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown