BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVE ADAPTIVE

    MDR report key: 21074520 · Received January 3, 2025

    Report

    Report Number
    3007593722-2024-00018
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 9, 2024
    Report Date
    September 30, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    FZX
    UDI-DI
    M9703400060000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CONFIRMED THE CORRECTION KNOB SEPARATED FROM THE JIG. THE COMPRESSION SCREW IS JAMMED, AND THE DISTRACTION KNOB/SCREW GETS STUCK/JAMMED. THIS IS THE FIRST COMPLAINT OPENED IN THE ENOVIS (AGILE) COMPLAINT SYSTEM SINCE THE ISSUING OF CAPA: CAR-00728 FOR EVOLVE34 LAPIDUS CORRECTION JIGS (3400-06-000 AND 3400-06-001) JIG KNOB AND CARBON FIBER MATERIAL BREAKAGE. THE LEGACY TRILLIAN/MEDSHAPE COMPLAINTS LISTED BELOW WERE CONFIRMED COMPLAINTS FOR THE JIG KNOB BREAKAGES AND THREE OF THE FIVE COMPLAINTS THAT WERE USED TO OPEN CAPA: CAR-00728. THE LEGACY CUSTOMER COMPLAINT REPORT (CCR) INFORMATION AND EVALUATION DOCUMENTS FOR THE LEGACY COMPLAINTS ARE ATTACHED TO PROVIDE FURTHER DETAILS ON EACH LEGACY COMPLAINT. CCR 23-12-013: EVOLVE34 CORRECTION JIG KNOB REPORTED TO SNAP OFF AFTER FIRST INITIAL TURN BY USER DURING IM REDUCTION. CCR 24-01-013: EVOLVE34 LAPIDUS CORRECTION JIG REPORTED TO HAVE THE COMPRESSION KNOB BREAK OFF WHEN COMPRESSING IN SURGERY. CCR 24-02-006: EVOLVE34 LAPIDUS CORRECTION JIG REPORTED TO HAVE THE COMPRESSION KNOB BREAK OFF WHEN COMPRESSING IN SURGERY. CONFIRMED THE 3400-06-000 LAPIDUS CORRECTION JIG, RIGHT DEVICE HAS A CORRECTION KNOB SEPARATED FROM THE JIG, COMPRESSION SCREW IS JAMMED, AND THE DISTRACTION KNOB/SCREW GETS STUCK/JAMMED. THE ROOT CAUSE IS BEING ADDRESSED IN AN EXISTING, OPEN CAPA: CAR-00728. NO NEW CAPA IS REQUIRED. THIS COMPLAINT WILL BECOME THE PARENT CASE AS IT CAPTURES THE THREE LEGACY TRILLIAN/MEDSHAPE CONFIRMED JIG KNOB BREAKAGE COMPLAINT EVALUATION/INVESTIGATIONS THAT WERE PART OF THE COMPLAINTS USED TO OPEN CAPA: CAR-00728 FOR EVOLVE34 LAPIDUS CORRECTION JIGS (3400-06-000 AND 3400-06-001) JIG KNOB AND CARBON FIBER MATERIAL BREAKAGE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL HAS BEEN CREATED TO UPDATE SECTION H6 . IF ADDITIONAL REPORTING ON THIS EVENT IS PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT.

    Description of Event or Problem · 0

    INSTRUMENT BREAKAGE - 30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950452 ACTIVE ADAPTIVE LAPIDUS CORRECTION JIG, RIGHT FZX MEDSHAPE, INC. UNKNOWN M9703400060000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other