BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE, 1.6MM, 4MM BEVELED FT

    MDR report key: 23366134 · Received October 23, 2025

    Report

    Report Number
    1220246-2025-04766
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867362376
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE OF AN AR-8741-15, BATCH 1197808, THAT DISPLAYS THE BROKEN GUIDE WIRE. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ERROR, SPECIFICALLY MISALIGNED INSERTION, PRYING/LEVERAGING, AND/OR APPLYING EXCESSIVE FORCE ON THE DEVICE DURING USE. PER DIRECTIONS FOR USE (DFU) DFU-0023-EO REVISION 5, INSTRUMENTS, I. CAUTIONS 1. USERS OF THIS DEVICE ARE ENCOURAGED TO CONTACT THEIR ARTHREX REPRESENTATIVES IF, IN THEIR PROFESSIONAL JUDGMENT, THEY REQUIRE A MORE COMPREHENSIVE SURGICAL TECHNIQUE OR MORE INFORMATION. ARTHREX PROVIDES DETAILED SURGICAL TECHNIQUES IN PRINT, VIDEO, AND ELECTRONIC FORMATS. THE ARTHREX WEBSITE ALSO PROVIDES DETAILED SURGICAL TECHNIQUE INFORMATION AND DEMONSTRATIONS. 2. TO AVOID DAMAGING THE INSTRUMENTS, DO NOT IMPACT OR SUBJECT TO BLUNT FORCE ANY INSTRUMENTS THAT ARE DESIGNED TO BE TURNED OR SCREWED IN. WHEN TWO DEVICES ARE INTENDED TO BE THREADED TOGETHER, ENSURE THAT THEY ARE FULLY ENGAGED PRIOR TO USE. 3. DO NOT USE ARTHREX INSTRUMENTS FOR ANY PURPOSE OTHER THAN THEIR INTENDED USE. MANIPULATING SOFT TISSUE OR BONE WITH AN INSTRUMENT NOT INTENDED FOR THAT USE MAY RESULT IN DAMAGE TO THE INSTRUMENT.

    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 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-8741-15 1.6 MM, 4MM BEVELED GUIDEWIRE BROKE DURING A CASE WITH NO PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727563 GUIDEWIRE, 1.6MM, 4MM BEVELED FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT 1197808 00888867362376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown