BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED

    MDR report key: 21867056 · Received April 18, 2025

    Report

    Report Number
    1220246-2025-01585
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 31, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00841435109582
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-9938-11 BATCH 672331 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION FOUND THAT A PIECE OF THE DEVICE'S JAWS WAS BROKEN OFF, AND THE SILICON INSERTER WAS NOT RETURNED FOR EVALUATION. THE DEVICE SHOWS DISCOLORATION SPOTS. FUNCTIONAL TESTING WAS PERFORMED BY PRESSING THE HANDLE TO CHECK FOR RESISTANCE OR ANY ISSUES. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, APPLYING EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    ON (B)(6) 2025 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER BROKE WHILE TRYING TO CUT THE SNAP OFF PINS. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763762 .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED 672331 00841435109582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown