BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED

    MDR report key: 22062853 · Received May 21, 2025

    Report

    Report Number
    1220246-2025-02154
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    August 25, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00841435109582
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ONE UNPACKAGED AR-9938-11 BATCH 672321 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED BECAUSE THE DEVICE WAS RECEIVED DAMAGED. VISUAL INSPECTION FOUND THAT ONE OF THE SILICONE INSERTS WAS MISSING. HEAVY SIGNS OF WEAR APPEAR AS THE LASER MARKS FADE, AND MANY DISCOLORATION SPOTS SURROUND THE INSTRUMENT. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE INSTRUMENT WAS MANUFACTURED IN 2023. THE COMPLAINT ALLEGATION WAS CONFIRMED.

    Description of Event or Problem · 0

    ON 05/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9938-11 WIRE CUTTER W/ SAFETY INSERT BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886640 .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. .062 WIRE CUTTER W/ SAFTY INSRT, ANGLED 672321 00841435109582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown