BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 10881544 · Received November 21, 2020

    Report

    Report Number
    9611053-2020-00357
    Event Type
    Malfunction
    Date Received
    November 21, 2020
    Report Date
    January 30, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRAGMENT OF RECIPROC BLUE FILE R25 8/100 25MM 025 RETURNED (HANDLE PART) HAS BEEN CUT BY THE CUSTOMER WITH A TOOL AND IS NOT EXPLOITABLE. THE SECOND FRAGMENT (ACTIVE PART) HAS NOT BEEN RETURNED SO NO ANALYSIS CAN BE MADE. NOTABLY FOR THIS REASON, NO LINK CAN BE ESTABLISHED BETWEEN BREAKAGE ISSUE AND INFORMATION FOUND DURING DHRS REVIEW (BATCHES #1380835, #1380418, #1381232, #1380417, #1370378, #1381543, #1381844, #1381220, #1379980, #1381688, #1381839 AND #1379981). PER BOUNDING WITH PREVIOUS COMPLAINTS PR#1602752 AND PR#1602753, SOME AVAILABLE UNUSED FILES HAD BEEN EVALUATED AND FOUND IN COMPLIANCE WITH SPECIFICATIONS. ACCORDING TO OUR PRESCRIPTIONS, WE CAN CONSIDER THAT THE PRODUCT VDW BATCH #192454 IS CONFORMING (REPRESENTATIVE SAMPLING). NO FAULT FOUND, PRODUCTION MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A RECIPROC BLUE BROKE DURING USE; THE BROKEN PART IS REMAINING IN THE ROOT CANAL, OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345921 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS DENTSPLY VDW GMBH NA 192454

    Patients

    Seq Age Sex Outcome Treatment
    1