BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    MDR report key: 22553464 · Received July 21, 2025

    Report

    Report Number
    8031010-2025-00118
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Report Date
    September 30, 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

    THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE INVOLVED WAVEONE GOLD PRIMARY FILE 25MM THAT BROKE DURING USE WAS NOT RETURNED PHYSICALLY AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1897070). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE, 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. DEVICE FOR THIS EVENT IS BEING CORRECTED FROM UNK MAILLEFER CATALOG # UNKNOWN TO WAVEONE GOLD PRIMARY 3-FILE STER 25MM CATALOG # A0753225G0P03. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE PRODUCT FOR THIS COMPLAINT SO THE COMPLAINT HAS BEEN REOPEN. PLEASE FIND THE UPDATED INVESTIGATION RESULTS. RETURNED WAVEONE GOLD PRIMARY FILE 25MM IS BROKEN AT THE TIP OF THE ACTIVE PART (TORQUE). 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 #1897070). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: TYPE OF INVESTIGATION - 4114. THE CORRECT CODES FOR THIS COMPLAINT ARE: TYPE OF INVESTIGATION - 10. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    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 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870223 WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown