BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 24506262 · Received March 4, 2026

    Report

    Report Number
    3000327445-2026-00002
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 4, 2026
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HWB
    UDI-DI
    07540194013095
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A HOSPITAL REPRESENTATIVE FROM THE UNITED KINGDOM REPORTED AN ISSUE INVOLVING A MALE RETRIEVER HANDLE (MR300). SPECIFICALLY, HE STATED THAT TWO MECHANICAL SCREWS WERE MISSING AND THE RATCHET MECHANISM WAS NOT FUNCTIONING. AS A RESULT, THE MALE COMPONENT DID NOT CONSTRICT AROUND THE IMPLANT DURING THE EXTRACTION PROCESS. DUE TO THE MALFUNCTION, THE SURGEON PERFORMED AN OSTEOTOMY TO REMOVE THE MALE COMPONENT MANUALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE EVENT RESULTED IN A SURGICAL DELAY EXCEEDING 30 MINUTES. THE HOSPITAL REPRESENTATIVE PROVIDED PHOTOGRAPHS OF THE RETRIEVER. THE REPRESENTATIVE CONFIRMED THAT THE SCREWS WERE ALREADY MISSING AT THE START OF THE CASE. HE COULD NOT DETERMINE WHETHER THE SCREWS WERE LOST WITHIN THE HOSPITAL AFTER THE TRAY ARRIVED OR WHETHER THE RETRIEVER HAD BEEN SHIPPED BY THE DISTRIBUTOR ALREADY MISSING THE SCREWS, AS THE DISTRIBUTOR DID NOT DETECT THE MISSING SCREWS BEFORE SENDING THE TRAY TO THE HOSPITAL. THE REPRESENTATIVE STATED THAT THE MISSING SCREWS RENDERED THE RETRIEVER UNUSABLE. HOWEVER, IT IS IMPORTANT TO NOTE THE FOLLOWING: · THE MECHANICAL SCREWS ONLY SECURE THE METAL CAP IN PLACE; THEY DO NOT DIRECTLY AFFECT THE TOOL'S ABILITY TO RETRIEVE THE IMPLANT. · IF THE SCREWS ARE MISSING, AN OPERATOR MAY NEED TO MANUALLY HOLD THE CAP, BUT THE RETRIEVAL FUNCTION REMAINS INTACT. · THE METAL CAP SERVES PRIMARILY AS A PROTECTIVE COVER FOR THE RATCHET MECHANISM. WITHOUT IT, MANIPULATION BECOMES MORE DIFFICULT, BUT FUNCTIONALITY IS NOT IMPAIRED. THE FACT THAT BOTH SCREWS WERE MISSING SIMULTANEOUSLY MAKES SPONTANEOUS LOOSENING UNLIKELY. A MORE REALISTIC POSSIBILITY IS THAT THE SCREWS WERE REMOVED OR LOOSENED BY HOSPITAL STAFF DURING CLEANING. HOWEVER, THE ASSEMBLY/DISASSEMBLY INSTRUCTIONS PROVIDED BY ORTHOPEDIATRICS CANADA EXPLICITLY STATE THAT THESE SCREWS SHOULD NOT BE REMOVED UNDER ANY CIRCUMSTANCES. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE TWO PLAUSIBLE SCENARIOS: 1. SCREWS LOST DURING HOSPITAL REPROCESSING · SCREWS REMOVED OR LOOSENED BY HOSPITAL STAFF DURING CLEANING. · ROOT CAUSE: USER ERROR / IMPROPER HANDLING. 2. SCREWS MISSING BEFORE SHIPMENT · SCREWS LOST BY THE DISTRIBUTOR PRIOR TO SHIPMENT. · ROOT CAUSE: IMPROPER REPROCESSING BY DISTRIBUTOR LEADING TO AN INCOMPLETE INSTRUMENT BEING SENT TO THE HOSPITAL. DUE TO THE LACK OF TRACEABLE INFORMATION FROM THE HOSPITAL, THE EXACT CAUSE CANNOT BE CONFIRMED. BUT BECAUSE THE SURGEON PERFORMED AN ADDITIONAL OSTEOTOMY, AND THE EVENT CAUSED A SURGERY DELAY > 30 MINUTES, THE INCIDENT WILL BE REPORTED TO FDA AND MHRA.

    Description of Event or Problem · 0

    A HOSPITAL REPRESENTATIVE FROM THE UNITED KINGDOM REPORTED AN ISSUE INVOLVING A MALE RETRIEVER HANDLE (MR300). SPECIFICALLY, HE STATED THAT TWO MECHANICAL SCREWS WERE MISSING AND THE RATCHET MECHANISM WAS NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186713 FASSIER-DUVAL TELESCOPIC IM SYSTEM MALE RETRIEVER - GENERATION III HWB ORTHOPEDIATRICS CANADA ULC G013-03 07540194013095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other