BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE, 1.6MM, 4MM BEVELED FT

    MDR report key: 18981022 · Received March 26, 2024

    Report

    Report Number
    1220246-2024-01660
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867362376
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 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. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 3/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A SURGEON HAS BEEN USING THE MIS BUNION SYSTEM FOR TWO YEARS AND WAS HAVING DIFFICULTY WITH TWO ARTHREX PRODUCTS, THE AR-8741-15 GUIDEWIRE AND THE AR-300-B102 BURR. WHEN USING THE AR-8741-15 GUIDEWIRE IT KEEPS GETTING STUCK WHEN SHOOTING THE K-WIRE WHEN DRILLING CAUSING THE SURGEON TO RE-FIND THE HOLE AND START OVER AGAIN. WHEN USING THE AR-300-B102 BURR IT KEEPS GETTING STUCK WHEN CUTTING WITH THE BURR AND WOULD NO LONGER CUT. THE CASES WERE COMPLETED AND NO ADVERSE EFFECTS WERE REPORTED ON ANY PATIENTS. THIS WAS DISCOVERED DURING CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433321 GUIDEWIRE, 1.6MM, 4MM BEVELED FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT UNK 00888867362376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown