BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFLEX CM FILE ASST 25MM

    MDR report key: 11019153 · Received December 16, 2020

    Report

    Report Number
    2416455-2020-00007
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 19, 2020
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EKS
    UDI-DI
    D661H825ASST1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. COMPLAINT ANALYSIS FROM THE LAST 12 MONTHS IDENTIFIES ONE ADDITIONAL COMPLAINT FOR BREAKING FILES. THAT COMPLAINT WAS SUBMITTED FROM THE SAME DENTIST OFFICE. ROOT CAUSE: NO PRODUCT WAS RETURNED FOR INVESTIGATION AND NO BATCH INFORMATION WAS PROVIDED SO A FULL ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. 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

    ASSISTANT AT THE OFFICE SAID THAT THE DOCTOR PERFORMED A ROOT CANAL PROCEDURE ON A FEMALE PATIENT ABOUT (B)(6) ON (B)(6). AS THE ROOT CANAL WAS BEING DONE, THE TIP OF THE FILE BROKE BUT IT WAS RETRIEVED AND DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489846 HYFLEX CM FILE ASST 25MM ENDODONTIC FILE EKS COLTENE WHALEDENT INC. H825ASST D661H825ASST1

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other