BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE, 1.6MM, 4MM BEVELED FT

    MDR report key: 16223209 · Received January 23, 2023

    Report

    Report Number
    1220246-2023-06144
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 28, 2022
    Report Date
    August 2, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867362376
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8741-15 GUIDEWIRE SNAPPED. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED ON 01/05/2023, IT WAS REPORTED THAT A MIS BUNION CASE TOOK PLACE ON (B)(6) 2022. THE DEVICE SNAPPED AT THE JUNCTION OF THE WIRE DRIVER. THE FRAGMENTS WERE RETRIEVED, AND A DIFFERENT K-WIRE WAS USED TO COMPLETE THE CASE. THE PATIENT HAD AVERAGE BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176703 GUIDEWIRE, 1.6MM, 4MM BEVELED FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT 1139856 00888867362376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown