BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTRIGGER TARGETING GUIDE

    MDR report key: 21667468 · Received March 21, 2025

    Report

    Report Number
    1220246-2025-01125
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 7, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867301832
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8973-01 OUTRIGGER TARGETING GUIDE BATCH NUMBER: 052210 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED A SCREW WAS VISIBLE THROUGH THE HUB ATTACHMENT TUBE AND WAS OBSERVED TO BE CAUSING AN OBSTRUCTION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE OBSTRUCTION NOTED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED/EXTENDED USAGE IN THE FIELD. MANUFACTURED DATE: 16-SEP-2022.

    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 03/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE WOULD NOT ALLOW THE ATTACHMENT SCREW ROD TO PASS THROUGH ITS RESPECTIVE SHEATH TO ENGAGE THE NAIL AND HOLD IT TO THE OUTRIGGER. IT SEEMS THERE IS A SCREW HALFWAY DOWN THE SHEATH OF THE OUTRIGGER THAT BLOCKS THE ATTACHMENT SCREW ROD. THE SCREW APPEARS TO BE PART OF THE OUTRIGGER, BUT THERE IS NO WAY TO REMOVE IT AS IT LOOKS INTERNAL. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907436 OUTRIGGER TARGETING GUIDE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. OUTRIGGER TARGETING GUIDE 052210 00888867301832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown