BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 17763625 · Received September 18, 2023

    Report

    Report Number
    9611053-2023-00847
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Report Date
    November 28, 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

    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.

    Additional Manufacturer Narrative · 0

    SUMMARY: SOME RECIPROC BLUE FILES R25 8/100 25MM 025 WERE RETURNED (ONE FILE IN LOOSE, TWO UNUSED FILES BATCH #392270 AND 24 UNUSED FILES BATCH #414834). THE FILE IN LOOSE IS ACTUALLY BROKEN AT THE TIP OF THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1813360, #1813359, #1767017, #1768463 AND #1769036). UNUSED FILES WERE EVALUATED: THE TWO FILES BATCH #392270 WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. ROOT CAUSES ARE NOT IDENTIFIED (AVAILABLE SAMPLING NOT REPRESENTATIVE). WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. A SAMPLE OF TEN FILES BATCH #414834 WAS TAKEN AND EVALUATED, FILES WERE FOUND IN COMPLIANCE WITH SPECIFICATIONS. NO FAULT WAS FOUND (REPRESENTATIVE SAMPLING). 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).

    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
    686202 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH 414834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown