BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SHAFT

    MDR report key: 23729133 · Received December 5, 2025

    Report

    Report Number
    1220246-2025-05445
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 14, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867524767
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED; WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT; ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS SUCH AS: (1) MECHANICAL OVERLOAD DURING REMOVAL OF THE LAG SCREW, RESULTING IN STRIPPING OF THE FLEXIBLE SHAFT, AND (2) RPROCESSING-RELATED FACTORS SUCH AS INCOMPLETE CLEANING OF THE DEVICE¿S INTERNAL LUMEN, CONTRIBUTING TO RESIDUAL DEBRIS INSIDE THE SHAFT.

    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 (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0222-200 FLEXIBLE SHAFT HAD BIO BURDEN STUCK IN IT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REPORTED BY THE REP ON 12/3/25 THAT THE DEVICE WAS STRIPPED AS IT WAS BEING REMOVED FROM THE LAG SCREW WHICH WAS IN THE PATIENT. THE AFFECTED PART OF THE CAPTURING ROD DID NOT TOUCH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547439 FLEXIBLE SHAFT PNEUMATIC PWR SURG INSTR MOTOR LXH ARTHREX, INC. FLEXIBLE SHAFT 220210 00888867524767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown