BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTEGRADE TARGETING MODULE

    MDR report key: 22029708 · Received May 15, 2025

    Report

    Report Number
    1220246-2025-02063
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 21, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665034073
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. ONE UNPACKAGED 1271-300 ANTEGRADE TARGETING MODULE BATCH NUMBER: 213098, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED DAMAGE TO THE THREADS OF THE DEVICE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO USER-APPLIED EXCESSIVE MECHANICAL FORCES. COMPLAINT ALLEGATION IS CONFIRMED. HOWEVER, WHETHER THIS WAS AN OUT-OF-BOX FAILURE CANNOT BE CONFIRMED DUE TO THE DAMAGE TO THE DEVICE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 1271-300 TARGETING MODULE DID NOT LINE UP AND WAS MISSING THE SCREW HOLE IN THE NAIL BY AT LEAST 6MM. WE WERE ABLE TO COMPLETE THE CASE WITH A FREEHAND LOCK. DELAYED US BY ABOUT 10 MINUTES AFTER WHICH THE CASE WAS COMPLETED WITHOUT ISSUE. NO ADVERSE PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67011 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