FASSIER-DUVAL TELESCOPIC IM SYSTEM

Additional Manufacturer Narrative

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.

Description of Event or Problem

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

Additional Manufacturer Narrative

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.