BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFLEX CM FILE ASST 25MM

    MDR report key: 10983935 · Received December 10, 2020

    Report

    Report Number
    2416455-2020-00006
    Event Type
    Malfunction
    Date Received
    December 10, 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 RESULTS: NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. THE RETURNED FILE WAS INSPECTED BY THE MATERIALS SCIENCE ENGINEER. HE NOTED THAT THERE ARE NO INTERNAL DEFECTS THAT WOULD BLAME THE FILE MATERIAL. HE NOTED THE BREAK IS FROM TORSION STARTING ON THE SURFACE AND PROPAGATING FROM THERE. BASED ON THE EVALUATION OF THE RETURNED MATERIAL THE MOST LIKELY ROOT CAUSE IS THAT THE USER IS USING THE FILES TOO MANY TIMES OR APPLYING EXCESSIVE FORCE OR SELECTING THE WRONG SIZE.

    Description of Event or Problem · 1

    ASSISTANT AT THE OFFICE SAID THAT THE DOCTOR PERFORMED A ROOT CANAL PROCEDURE ON A MALE PATIENT EITHER (B)(6) OR (B)(6)YEARS OLD. WHILE THE DOCTOR WAS PERFORMING THE ROOT CANAL, THE TIP OF THE FILE BROKE, BUT IT WAS NOT ABLE TO BE RETRIEVED, AND THE PIECE THAT BROKE WAS LEFT IN THE PATIENT'S CANAL. THE PATIENT DID NOT REPORT ANY DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453039 HYFLEX CM FILE ASST 25MM ENDODONTIC FILE EKS COLTENE WHALEDENT INC. H825ASST D661H825ASST1

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other