BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTEGRADE TARGETING MODULE

    MDR report key: 18419657 · Received December 29, 2023

    Report

    Report Number
    1220246-2023-09775
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 1, 2023
    Report Date
    August 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665034073
    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

    COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED 1271-300 ANTEGRADE TARGETING MODULE BATCH NUMBER: 213098 WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION NOTED NO PROBLEMS WITH THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED WITH AN 0624-000 SCREW SHEATH BATCH NUMBER: 201243 BY PLACING THE SCREW SHEATH THROUGH THE APPROPRIATE TRANSVERSE HOLE IN THE TARGETING GUIDE. IT WAS NOTED THAT THE SCREW SHEATH FIT WELL WITHIN THE 1271-300 ANTEGRADE TARGETING MODULE AND WAS NOT LOOSE AT ALL. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(46.THAT A 1271-300 ANTEGRADE TARGETING MODULE HAD AN ISSUE WITH THE SCREW SHEATH BEING LOOSE ON THE JIG AND THEREFORE MISSING THE NAIL IMPLANT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244966 ANTEGRADE TARGETING MODULE INTRAMED FIXATN ROD AND ACCESS LXH ARTHREX, INC. ANTEGRADE TARGETING MODULE 213098 00848665034073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown