BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 23267716 · Received October 10, 2025

    Report

    Report Number
    3000327445-2025-00005
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    July 30, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT THE HEX CARTRIDGE (FRT240-HEX) BROKE IN SITU, MAKING THE IMPLANT REMOVAL PROCEDURE SIGNIFICANTLY MORE DIFFICULT. THE ISSUE DID NOT REQUIRE REVISION SURGERY. THE IMPLANT WAS REMOVED USING OTHER INSTRUMENTS AVAILABLE IN THE HOSPITAL. THE SURGERY WAS ULTIMATELY COMPLETED SUCCESSFULLY BUT REQUIRED ADDITIONAL OSTEOTOMY ALONG WITH THE USE OF OTHER INSTRUMENTS DUE TO THE FAILURE OF THE CARTRIDGE. A PREVIOUS COMPLAINT INVOLVING THE OLDER VERSION OF THE FRT240-HEX REVEALED THAT OVERTIGHTENING THE COMPONENT OUTSIDE OF THE FEMALE RETRIEVER COULD LEAD TO PERMANENT DEFORMATION AND SUBSEQUENT FAILURE. THIS FINDING LED TO THE INITIATION OF A CAPA AND THE DEVELOPMENT OF A REDESIGNED FRT240-HEX, WHICH WAS RELEASED FOR SALE IN DECEMBER 2023. FOR THE CURRENT CASE, THE SPECIFIC UNIT WAS TRACED TO LOT #F462-03 AND CONFIRMED TO BE PART OF THE NEW FRT240-HEX DESIGN. THIS COMPLAINT THEREFORE REPRESENTS THE FIRST REPORTED OCCURRENCE OF BREAKAGE WITH THE NEW DESIGN. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, AND ALTHOUGH ADDITIONAL INFORMATION WAS GATHERED FROM THE HOSPITAL, IT DID NOT ALLOW DETERMINATION OF THE ROOT CAUSE OR CONFIRMATION OF WHETHER THIS WAS A DEVICE MALFUNCTION. AT PRESENT, THE ROOT CAUSE REMAINS UNDETERMINED. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THE NEW DESIGN SINCE ITS RELEASE, AND THERE IS INSUFFICIENT EVIDENCE TO ATTRIBUTE THE EVENT TO A DEVICE-RELATED MALFUNCTION. CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME DUE TO THE ISOLATED NATURE OF THE EVENT AND THE ABSENCE OF A CONFIRMED DEVICE MALFUNCTION AND ORIGIN OF THE FAILURE. COMPLAINT TRENDING WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE NEW DESIGN, AND A FORMAL INVESTIGATION WILL BE RE-OPENED IF ADDITIONAL OCCURRENCES ARE REPORTED.

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT THE HEX CARTRIDGE BROKE INSITU WHICH CAUSED THE IMPLANT REMOVAL TO BE VERY CHALLENGING. THE ISSUE NECESSITATED A REVISION PROCEDURE AND RESULTED IN A SURGICAL DELAY EXCEEDING 30 MINUTES. IT IS NOT YET CONFIRMED WHETHER A MALFUNCTION OCCURRED. THE HOSPITAL REPRESENTATIVE HAS BEEN CONTACTED FOR CLARIFICATION, BUT NO INFORMATION HAS BEEN RECEIVED SO FAR. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR ON AUGUST 29, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (B)(4). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT THE HEX CARTRIDGE BROKE INSITU WHICH CAUSED THE IMPLANT REMOVAL TO BE VERY CHALLENGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935048 FASSIER-DUVAL TELESCOPIC IM SYSTEM X.X CARTRIDGE LXH ORTHOPEDIATRICS CANADA ULC F462-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other