BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD SMALL 6-FILE STER 25MM

    MDR report key: 20522398 · Received October 24, 2024

    Report

    Report Number
    8031010-2024-00128
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    August 19, 2024
    Report Date
    December 5, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D716WGSMALL251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS SUMMARY: 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 #1820873). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE (MUPLTIPLE REUSES MAY INCREASE RISKS OF BREAKAGE- NUMBER OF USE NOT FORMALLY KNOWN), EXCESSIVE WEAR, OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). WE MOREOVER DRAW CUSTOMER ATTENTION ABOUT THE FACT THAT WAVEONE GOLD FILES ARE SINGLE USE ITEMS.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD SMALL 6-FILE STER 25MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714235 WAVEONE GOLD SMALL 6-FILE STER 25MM FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1820873 D716WGSMALL251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown