BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE, 1.6X150MM, CAPITAL FRAG

    MDR report key: 16906729 · Received May 10, 2023

    Report

    Report Number
    1220246-2023-06709
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 14, 2023
    Report Date
    October 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867362390
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    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

    COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE AND EXCESSIVE FORCE APPLIED DURING INSERTION.

    Description of Event or Problem · 0

    ON 4/14/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT DURING AN OFFICE VISIT, THE DOCTOR MENTIONED THAT AN ARTHREX TOOL USED FOR SURGERIES GETS TOO HOT THAT IT LEAVES A BURN MARK, "LIKE A BRAND," ON HIS PATIENTS. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/19/2023: PART NUMBER AR-8741-14 GUIDEWIRE, 1.4 MM, FOR 3.5 MM AND AR-8741-16 CAPITAL FRAGMENT GUIDEWIRE 1.6MM WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/19/2023: PER THE SALES REPRESENTATIVE THAT WAS PRESENT DURING THE PROCEDURE, THIS WAS A MIS BUNION SURGERY, THE EXACT DATE IS UNKNOWN. IT IS ALSO UNKNOWN WHICH PART AR-8741-14 OR AR-8741-16 CAUSED THE PATIENT'S BURN. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227953 GUIDEWIRE, 1.6X150MM, CAPITAL FRAG ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GUIDEWIRE, 1.6X150MM, CAPITAL FRAG UNK 00888867362390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other