BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 19296852 · Received May 13, 2024

    Report

    Report Number
    9611053-2024-00084
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Report Date
    July 17, 2024
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: 18 RECIPROC BLUE FILES R25 8/100 25MM 025 WERE RETURNED (2 FILES IN LOOSE + 16 UNUSED FILES). ONE OF THE FILES IN LOOSE IS BROKEN IN THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. SECOND FILE IN LOOSE HAS NO DAMAGE AND SEEMS UNUSED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1850066). A SAMPLE OF 10 UNUSED FILES WAS TAKEN AND EVALUATED AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS. ACCORDING TO OUR PRESCRIPTIONS, WE CAN CONSIDER THAT THE PRODUCTION BATCH #1850066 IS CONFORMING (REPRESENTATIVE SAMPLING). NO FAULT WAS FOUND, PRODUCTION MEETS SPECIFICATIONS. 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).

    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 RESULTS ARE NOT AVAILABLE 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 BLUE FILES, 6X, STERILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE CANAL. FURTHER TREATMENT IS PLANNED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457474 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 1850066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown