BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT

    MDR report key: 22883154 · Received August 25, 2025

    Report

    Report Number
    1220246-2025-03611
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 31, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867524767
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PICTURES. VISUAL EVALUATION OF THE CUSTOMER-PROVIDED PICTURES NOTED AN UNRAVELED HUMERAL NAIL SYSTEM 0222-200 FLEXIBLE REAMER. REFER TO ATTACHMENTS. BASED ON THE INFORMATION PROVIDED, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO RUNNING THE HUMERAL CANAL REAMER IN REVERSE. DOING SO WILL CAUSE THE SHAFT OF THE REAMER TO UNRAVEL. REF: LT1-000241-EN-US HUMERAL NAIL SYSTEM SURGICAL TECHNIQUE GUIDES.

    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 07/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 0222-200 FLEXIBLE SHAFT OUTER PART CAME UNRAVELED WHILE REAMING. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 8/8/25 THAT THE DEVICE WAS RUN IN REVERSE WHEN THE DEVICE BEGAN TO UNRAVEL. ADDITIONAL INFORMATION RECEIVED BY THE SALES REP 08/18/25 THAT NO FRAGMENTS OR PIECES REMAINED IN THE PATIENT. WHEN IT UNRAVELED IT UNCOILED BUT REMAINED IN ONE PIECE. PHOTO WAS PROVIDED AND ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335371 FLEXIBLE SHAFT PNEUMATIC PWR SURG INSTR MOTOR LXH ARTHREX, INC. FLEXIBLE SHAFT 231124 00888867524767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown