BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 18622281 · Received February 1, 2024

    Report

    Report Number
    9611053-2024-00014
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Report Date
    February 26, 2024
    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 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    SUMMARY: INVOLVED PRODUCTS WHICH BROKE DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1760628, #1760931, #1763768, #1760627, #1761739, #1764586, #1765158, #1764627, #1765624, #1764600 AND #1763562). THE TWO UNUSED RECIPROC BLUE FILES R25 8/100 25MM 025 WHICH WERE RETURNED 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. FOR INFORMATION, WE REMIND THE PRACTITIONER HAS TO MAKE SURE THAT A STRAIGHT-LINE ACCESS IS CREATED PRIOR USING THE RECIPROC BLUE FILES (AS MENTIONED IN THE DFU).

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT RECIPROC BLUE FILES, 6X, STERILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419835 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 390052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown