BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 6-FILE STER 25MM

    MDR report key: 22912012 · Received August 28, 2025

    Report

    Report Number
    8031010-2025-00145
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    July 26, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716WGPRIME251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE RETURNED WAVEONE GOLD PRIMARY FILE 25MM IS BROKEN AT THE TIP OF THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1860947). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE BROKE DURING USE. THE ROOT CANAL TREATMENT WAS STOPPED DUE TO THE FILE SUDDENLY BREAKING. THE BROKEN PART WAS CAREFULLY REMOVED, ENSURING THAT NO FRAGMENTS REMAINED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834153 WAVEONE GOLD PRIMARY 6-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1860947 D716WGPRIME251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown