BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 24099602 · Received January 16, 2026

    Report

    Report Number
    3000327445-2026-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 4, 2026
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    OJH
    PMA / PMN Number
    K041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, A HOSPITAL REPRESENTATIVE AT (B)(6) REPORTED THAT WHILE CLEANING A FASSIER-DUVAL RESCUE RENTAL TRAY, THE HOSPITAL STAFF NOTICED MASSIVE AMOUNTS OF BIOBURDEN IN THE CANNULATED ITEMS. AFTER THE TRAY WAS SENT BACK TO ORTHOPEDIATRICS CANADA, IT WAS RE-INSPECTED. IT WAS CONFIRMED THAT MULTIPLE CANNULATED INSTRUMENTS HAD ORGANIC RESIDUE INSIDE. THE INVESTIGATION IS ON GOING AND WILL REQUIRE MORE TIME TO DEFINE THE ROOT CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 0

    ON DECEMBER 18, 2025, A REPRESENTATIVE FROM CHEO REPORTED THAT DURING CLEANING OF THE FASSIER DUVAL RESCUE RENTAL TRAY (FD RESCSET 319), HOSPITAL STAFF OBSERVED SIGNIFICANT BIOBURDEN INSIDE MULTIPLE CANNULATED INSTRUMENTS. THE HOSPITAL REPRESENTATIVE DECIDED NOT TO USE THE TRAY AND ASKED FOR A REPLACEMENT. THERE WAS NO PATIENT INJURY, AS THE ISSUE WAS DISCOVERED BEFORE SURGERY, AND THERE WAS NO SURGERY DELAY OR CANCELLATION BECAUSE A REPLACEMENT TRAY WAS SHIPPED TO THE HOSPITAL IMMEDIATELY. AFTER THE TRAY WAS RETURNED TO ORTHOPEDIATRICS CANADA, IT WAS RE INSPECTED, BUT NO PRESENCE OF ORGANIC RESIDUE WAS CONFIRMED AS THE TRAY HAS BEEN CLEANED IN THE HOSPITAL PRIOR TO THE RETURN. A MEETING WITH QUALITY, INVENTORY, AND PRODUCTION MANAGEMENT WAS HELD TO ASSESS THE ISSUE. THE INITIAL FINDINGS SHOWED THAT THE RENTAL TRAY HAD BEEN REPROCESSED ACCORDING TO COMPANY PROCEDURES FOLLOWING ITS PREVIOUS USE. AFTER BEING RETURNED FROM THE PRIOR SURGERY, THE TRAY UNDERWENT INCOMING INSPECTION, CLEANING/REPROCESSING, AND RELEASE TO INVENTORY IN ACCORDANCE WITH ESTABLISHED PROTOCOLS. TO ENSURE THE ISSUE WAS ISOLATED, THE ENTIRE ORTHOPEDIATRICS CANADA TRAY RENTAL POOL WAS IMMEDIATELY RE INSPECTED, AND NO OTHER TRAYS WERE FOUND WITH BIOBURDEN OR ANY OTHER RESIDUE, CONFIRMING THAT THIS WAS THE ONLY TRAY AFFECTED. ADDITIONALLY, THE PROCESSES FOR RECEPTION OF RETURNED TRAYS, INSPECTION, CLEANING, AND RELEASE TO INVENTORY WERE AUDITED, AND ALL STEPS WERE CONFIRMED TO HAVE BEEN PERFORMED CORRECTLY WITH NO DEVIATIONS IDENTIFIED. BASED ON THE AVAILABLE EVIDENCE, THERE IS NO INDICATION OF A SYSTEMIC PROCESS FAILURE IN CLEANING, INSPECTION, OR REPROCESSING, AND NO SIMILAR ISSUES WERE OBSERVED IN THE REMAINING RENTAL POOL. PROCEDURES WERE FOLLOWED PROPERLY, AND THE PROCESS AUDITS DID NOT REVEAL ANY GAPS. THEREFORE, THE MOST PLAUSIBLE ASSESSMENT IS THAT THE ISSUE RESULTED FROM AN ISOLATED MISHANDLING EVENT RATHER THAN A SYSTEMIC OR PROCESS-RELATED FAILURE. HOWEVER, SINCE THE INSTRUMENT TRAY WAS PROCESSED, RELEASED, AND SHIPPED BY ORTHOPEDIATRICS CANADA, THE ROOT CAUSE IS STILL ATTRIBUTABLE TO THE MANUFACTURER. A CORRECTIVE AND PREVENTIVE ACTION (CPA) WILL BE INITIATED TO INVESTIGATE THE PRECISE ROOT CAUSE IN GREATER DETAIL, IDENTIFY ANY CONTRIBUTING FACTORS, IMPLEMENT THE NECESSARY CORRECTIVE ACTIONS, AND ENSURE PREVENTION OF RECURRENCE.

    Description of Event or Problem · 0

    THE HOSPITAL STAFF REPORTED THAT UPON INSPECTION AFTER CLEANING OF THE LOANER RESCUE SET, ORGANIC RESIDUE WAS OBSERVED INSIDE MULTIPLE CANNULATED INSTRUMENTS DURING CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118854 FASSIER-DUVAL TELESCOPIC IM SYSTEM FULL FD RESCUE CASE RENTAL - GENERATION III OJH ORTHOPEDIATRICS CANADA ULC FD-RESCRENT-3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other