BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM

    MDR report key: 9573186 · Received January 9, 2020

    Report

    Report Number
    2320721-2019-00284
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Report Date
    March 4, 2020
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED 2 FILES IN AUTOCLAVE BAG, ALONG WITH 3 UNOPENED FILES IN PACK. USING MICROSCOPE VISUALLY CHECKED FILES FROM AUTOCLAVE BAG. ONE OF THE FILES WAS BROKEN AT APPROXIMATELY 20MM. APPROXIMATELY 5MM OF THE FILE WAS BROKEN OFF. THE OTHER FILE HAD BEEN USED AND WAS BENT AT THE TIP. NO MANUFACTURING MARKINGS OR DEFECTS NOTED ON EITHER OF THE FILES. USING MICROSCOPE VISUALLY CHECKED UNOPENED FILES. NO MANUFACTURING MARKINGS OR DEFECTS NOTED ON THESE FILES. UNUSED FILES WERE TESTED BY MANUFACTURING / LORI OGLE: SPECIFICATION @ 3 MM- .470 MM +/-.020 @ 9 MM -.845 MM +/-.030 1) .476 MM .838 MM 2) .474 MM .837 MM 3) .476 MM .846 MM FILES MEASURED WITHIN SPECIFICATION. NOTHING FOUND WRONG WITH UNUSED FILES. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW.

    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. THIS REPORT IS FOR THE FIRST DEVICE. 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 TWO WAVEONE GOLD RECIPROCATIONG FILES BROKE IN THE SAME PATIENT, SAME TOOTH. THE FILE REMAINED IN THE TOOTH AS PART OF THE FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36222 WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE, PULP CANAL, ENDODONTIC EKS TULSA DENTAL PRODUCTS LLC NA 24073628

    Patients

    Seq Age Sex Outcome Treatment
    1