BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    MDR report key: 23166577 · Received September 29, 2025

    Report

    Report Number
    8031010-2025-00171
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Report Date
    November 13, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: EIGHT WAVEONE GOLD PRIMARY FILES 25MM WERE RETURNED (TWO FILES IN LOOSE AND SIX UNUSED FILES). THE FILES IN LOOSE ARE BOTH BROKEN IN THE ACTIVE PART (TORQUE; FATIGUE). SECOND FILE IN LOOSE HAS NO MORE ABS RING. RING WAS VOLUNTARILY REMOVED TO ALLOW THE REUSE OF THE INSTRUMENT (BREAKAGE OCCURRED DURING THE REUSE ACCORDING TO THE CUSTOMER ALLEGEMENT). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1897070). THE SIX UNUSED FILES WERE EVALUATED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED REGARDING FIRST BROKEN FILE. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ROOT CAUSE IS CUSTOMER MISUSE REGARDING SECOND BROKEN FILE. INDEED, WAVEONE GOLD FILES ARE SINGLE USE STERILE ITEMS WHICH MUST NOT BE STERILIZED AND REUSED.

    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. TREATMENT COMPLETED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144804 WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1897070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown