BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC FILES 6X

    MDR report key: 20224935 · Received September 16, 2024

    Report

    Report Number
    9611053-2024-00172
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Report Date
    December 9, 2024
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVOLVED PRODUCT BROKEN DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1861652). THE FOUR UNUSED RECIPROC 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. 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 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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A RECIPROCAL FILES 6X BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. TREATMENT IS PLANNED TO REMOVE THE BROKEN PART. AS OF THIS MDR THE OUTCOME IS UNKNOWN. REQUESTED FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667646 RECIPROC FILES 6X FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 1861652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown