BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 4X

    MDR report key: 21251263 · Received January 28, 2025

    Report

    Report Number
    9611053-2025-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Report Date
    April 7, 2025
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THIS CASE WAS FOR 2 INSTRUMENTS BROKEN AT 1 PATIENT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: TWO RECIPROC FILES R25 8/100 25MM 025 WERE RETURNED IN LOOSE. THE FILES ARE BOTH BROKEN AT THE TIP OF THE ACTIVE PART (FATIGUE; TORQUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCHES #1852998, #1856461, #1856460 AND #1856461). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. 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

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RECIPROC FILES 4X FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND REMAINS IN THE ROOT CANAL. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606361 RECIPROC FILES 4X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 446618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown