BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 18334295 · Received December 15, 2023

    Report

    Report Number
    9611053-2023-00890
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Report Date
    February 21, 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

    SUMMARY: THE RECIPROC BLUE FILE R50 5/100 31MM 050 RETURNED IN LOOSE IS BROKEN AT THE BASE OF THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1768752, #1771374 AND #1781464). 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 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 RECIPROC BLUE FILES, 6X, STERILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. 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
    2268370 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown