BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW.ROTATE 15.04 6-FILES 25MM

    MDR report key: 16252876 · Received January 27, 2023

    Report

    Report Number
    9611053-2023-00721
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Report Date
    February 2, 2023
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    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 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

    ADDITIONAL INFORMATION RECEIVED, THE BROKEN PARTS WERE EASILY RETRIEVED AND NO INJURY RESULTED, SO EXEMPTION # E2005009 APPLIES AND THIS EVENT IS NOT REPORTABLE. INVESTIGATION 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 DHRS REVIEW (BATCHES #1771766, #1773463 AND #1781086). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A VDW. ROTATE 15.04 6-FILES 25MM BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. FURTHER TREATMENT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5378 VDW.ROTATE 15.04 6-FILES 25MM FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 399498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown