BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 18487112 · Received January 10, 2024

    Report

    Report Number
    1220246-2024-00251
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    September 29, 2023
    Report Date
    January 30, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 12/11/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT DURING A PROCEDURE, RIGHT ELBOW OPEN REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT AND RIGHT ELBOW ULNAR COLLATERAL LIGAMENT RECONSTRUCTION WITH PALMARIS LONGUS AUTOGRAFT WITH INTERNAL BRACE, A SMALL METALLIC FRAGMENT OF ANCHOR INSERTION DEVICE EMBEDDED INTO THE ULNA AT THE SUBLIME TUBERCLE. THE FOREIGN BODY WAS UNABLE TO BE REMOVED WITHOUT CAUSING PATIENT HARM OR INJURY, THEREFORE, IT WAS INTENTIONALLY RETAINED. THE PROCEDURE TOOK PLACE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003140 UNK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown