BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 18020311 · Received October 27, 2023

    Report

    Report Number
    9611053-2023-00869
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Report Date
    December 28, 2023
    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

    ADDITIONAL INFORMATION RECEIVED THAT AFTER FURTHER TREATMENT OF TRYING TO REMOVE THE BROKEN PART; THE BROKEN PART REMAINS IN THE ROOT CANAL. THE BROKEN PART WAS INCORPORATED INTO THE FILLING. INVESTIGATION: SUMMARY: THE RETURNED RECIPROC BLUE FILE R25 8/100 31MM 025 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 DHR REVIEW (BATCH #1780385). 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). DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM RECIPROC FILES 6X CATALOG # V040212031025 TO RECIPROC BLUE FILES, 6X, STERILE CATALOG # V040252031025.

    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 FILES 6X BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL. FURTHER TREATMENT PENDING. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150325 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 397897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown