BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFLEX CM FILE ASST 31MM

    MDR report key: 9579310 · Received January 11, 2020

    Report

    Report Number
    2416455-2020-00001
    Event Type
    Injury
    Date Received
    January 11, 2020
    Date of Event
    December 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EKS
    UDI-DI
    D661600184601
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BATCH RECORDS WERE REVIEWED. THERE WERE NO ISSUES IDENTIFIED THAT INDICATE A MANUFACTURING DEFECT WAS PRESENT. ROOT CAUSE: NO PRODUCT WAS RETURNED FOR INVESTIGATION SO A FULL ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. AS IDENTIFIED IN THE PRODUCT RISK FILE, (B)(4), THE FOLLOWING MAY BE A POTENTIAL ROOT CAUSE OF THE FILE BREAKING: FILE IS USED MULTIPLE TIMES. FILE NOT HEAT TREATED PROPERLY TO REQUIRED SPECIFICATIONS. EXCESSIVE FORCE APPLIED BY THE USER. USER CHOSE THE WRONG SIZE FILE.

    Description of Event or Problem · 1

    DOCTOR WAS USING OUR HYFLEX CM FILES AND EXPERIENCE SEPARATION IN THE CANAL ON THE FIRST USE OF THE FILE. THE FILE HAD NOT BEEN USED PRIOR TO THIS CASE AND WAS BRAND NEW. DOCTOR COMPLAINS THAT UPON TORSIONAL LOAD OF LESS THAN 2.5NCM (HE HAD HIS TORQUE RATING PROPERLY SET) THE FILE SEPARATED AT THE STOP SECTION. IT DID NOT SEPARATE AT THE MANDREL BUT INSTEAD ABOUT 2MM DOWN FROM WHERE THE SPIRAL PART OF THE FILE BEGINS. IT WAS FILE 04/25 THAT BROKE FROM THE SET. THERE WAS NO PATIENT INJURY. THE CUSTOMER LATER INDICATED THAT THE EVENT HAPPENED DURING PROCEDURE AND HE HAD HAND FILED. HE SAID HE HAND FILES FOR EVERY CASE. THE DOCTOR INDICATED SIZE 15, BUT DID NOT RECALL IF HE USED OUR GLIDEPATH FILE. THE DOCTOR HAD TO BUY A THIRD PARTY INSTRUMENT IN ORDER TO REMOVE THE SEPARATED FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42199 HYFLEX CM FILE ASST 31MM ENDODONTIC FILE EKS COLTENE WHALEDENT INC. I85846 D661600184601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention