BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED

    MDR report key: 21936834 · Received April 30, 2025

    Report

    Report Number
    1220246-2025-01802
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    April 7, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00841435109582
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. DUE TO PHOTOGRAPHIC EVIDENCE PROVIDED FROM THE FIELD OF AN AR-9938-11, WITH BATCH NUMBER 672207, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR. DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO IT, THE DEVICE WILL INEVITABLY SUSTAIN DAMAGE OVER TIME.

    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 04/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-9938-11 .062 WIRE CUTTER WAS BROKEN. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TALAR OATS PROCEDURE ON 04/07/2025, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300702 .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED 672207 00841435109582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown