BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT

    MDR report key: 21537400 · Received March 6, 2025

    Report

    Report Number
    1220246-2025-00832
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 15, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665023688
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 0222-200 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION REVEALED THAT THE DEVICE TIP WAS BROKEN OFF. CORROSION WAS OBSERVED ON THE LASER MARKS. THE THREADS AT THE PROXIMAL END WERE BENT. SCRATCHES AND MARKS WERE ALSO NOTED ON THE SHAFT, AND THE SHAFT LENGTH WAS BENT. FUNCTIONAL TESTING CANNOT BE PERFORMED AS THE DEVICE WAS BROKEN WHEN RECEIVED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS THE DEVICE'S WEAR AND TEAR AFTER MANY RE-PROCESSINGS AND USES.

    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 02/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0222-200 FLEXIBLE REAMER SHAFT BROKE. THIS OCCURRED DURING A CASE WHERE THE PIECE WAS RECOVERED AND THE CASE WAS COMPLETED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828941 FLEXIBLE SHAFT PNEUMATIC PWR SURG INSTR MOTOR LXH ARTHREX, INC. FLEXIBLE SHAFT 00848665023688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown