BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXMASTER TAPER 04 STERILE

    MDR report key: 19891280 · Received August 2, 2024

    Report

    Report Number
    9611053-2024-00123
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Report Date
    September 26, 2024
    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

    TWO FLEXMASTER FILES .04 21MM 020 WERE RETURNED IN LOOSE. FIRST ONE IS BROKEN AT THE TIP OF THE ACTIVE PART (FATIGUE), SECOND ONE IS BROKEN IN THE ACTIVE PART (FATIGUE). NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. FOR INFORMATION, THIRD FLEXMASTER FILE .04 21MM 020 WHICH BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1780144). 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 FLEXMASTER TAPER 04 STERILE FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983923 FLEXMASTER TAPER 04 STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown