BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD PRIMARY 3-FILE STER 25MM

    MDR report key: 23096147 · Received September 19, 2025

    Report

    Report Number
    8031010-2025-00157
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716WGPRIME251
    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: 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 ALIGNMENT). 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. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE. 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. CORRECTING CODE - REMOVING PREVIOUSLY REPORTED TYPE OF INVESTIGATION CODE 4114. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SUMMARY: 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 #(B)(4)). 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. ADDITIONAL INFORMATION RECEIVED: THE PATIENT DID NOT SUFFER ANY INJURY. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT'S MOUTH. THE INSTRUMENT WAS USED FOR THE FIRST TIME AND BROKE, SO ANOTHER INSTRUMENT WAS USED AND ALSO BROKE ON FIRST USE. NO MEDICAL OR SURGICAL TREATMENT WAS NECESSARY AFTER THE EVENT. TREATMENT WAS NOT COMPLETED.

    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 PARTS REMAIN IN PATIENT'S TOOTH. NO INJURY OCCURRED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759844 WAVEONE GOLD PRIMARY 3-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1897070 D716WGPRIME251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown