BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 22574648 · Received July 23, 2025

    Report

    Report Number
    9611053-2025-00101
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Report Date
    November 20, 2025
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 21 CFR 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

    THREE RECIPROC FILES R25 8/100 21MM 025 WERE RETURNED (ONE FILE IN LOOSE + TWO UNUSED FILES). FILE IN LOOSE IS BROKEN AT THE TIP OF THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1896874). UNUSED FILES WERE EVALUATED AND WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED. 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.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT A RECIPROC FILES 6X FILE BROKE DURING USE. THE BROKEN PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938490 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH UNKNOWN - WILL BE REQUESTED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown