BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 23727191 · Received December 5, 2025

    Report

    Report Number
    9611053-2025-00165
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Report Date
    December 30, 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

    INVESTIGATION RESULTS THE RETURNED RECIPROC FILE R40 6/100 25MM 040 IS BROKEN AT THE BASE 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 (BATCHES #1821400, #1823440 AND #1864670 MANUFACTURED IN 2013). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. FOR INFORMATION, THIS PRODUCT IS MANUFACTURED BY MAILLEFER FOR VDW, IT'S UP TO VDW TO MAKE SURE THAT THE PRODUCT HAS BEEN USED IN COMPLIANCE WITH DFU. ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THIS EVENT WILL BE REEVALUATED, AS APPROPRIATE, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RECIPROC FILES 6X FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND FURTHER TREATMENT IS PENDING. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473762 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 044864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown