BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED

    MDR report key: 22282404 · Received June 18, 2025

    Report

    Report Number
    1220246-2025-02505
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00841435109582
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 COMPLAINT ALLEGATION IS CONFIRMED. A VISUAL EVALUATION NOTED THAT ONE OF THE SILICONE INSERTERS WAS BROKEN OFF. LASER MARKS THAT HAD FADED AND RUSTED WERE ALSO NOTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS NORMAL WEAR AND TEAR DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO THE DEVICE, WHICH WILL INEVITABLY SUSTAIN DAMAGE OVER TIME.

    Description of Event or Problem · 0

    ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER CLAMP BROKE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496262 .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