BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMANO FORTIS REUSABLE LEG HOLDER

    MDR report key: 19972996 · Received August 13, 2024

    Report

    Report Number
    1220246-2024-07160
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 18, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    BWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER BATCH 68750168 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, THE BASE PLATE WAS BENT CLOSED WHERE THE ATTACHMENT IS. THE RIVET WAS MISSING, MOST LIKELY BECAUSE OF THE BENT. THE MOST LIKELY CAUSE OF THIS CONDITION IS MISUSE BY THE END USER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 07/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAD ONE OF THE SCREWS BREAK OUT DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619077 TRIMANO FORTIS REUSABLE LEG HOLDER OPERATING ROOM TABLE ACCESS BWN ARTHREX, INC. TRIMANO FORTIS REUSABLE LEG HOLDER 68750168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown