BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 18624930 · Received February 1, 2024

    Report

    Report Number
    9611053-2024-00016
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Report Date
    April 4, 2024
    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

    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 DHR REVIEW (BATCHES #1778430 AND #1781000). 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).

    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 RECIPROC FILES 6X BROKE DURING USE. THE BROKEN PART REMAIN IN THE ROOT CANAL. FURTHER TREATMENT IS PLANNED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108685 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 397647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown