BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 17049722 · Received June 2, 2023

    Report

    Report Number
    9611053-2023-00799
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Report Date
    August 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

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT 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

    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 (BATCH #1800946). 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

    ADDITIONAL INFORMATION RECEIVED: THE BROKEN PART REMAINS IN THE ROOT CANAL. THE BROKEN PART WAS INCORPORATED INTO THE FILLING. TREATMENT IS NOT COMPLETE. FURTHER TREATMENT IS TOOTH EXTRACTION IF THE BROKEN PART CANNOT BE REMOVED. FURTHER INFORMATION REQUESTED AS TO THE OUTCOME OF TREATMENT. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE IT IS AVAILABLE. INVESTIGATION RESULTS ARE PENDING AND WILL BE SUBMITTED ONCE THEY ARE AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT RECIPROC BLUE FILES, 6X, STERILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622195 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown