BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTRIGGER TARGETING GUIDE

    MDR report key: 12770692 · Received November 8, 2021

    Report

    Report Number
    1220246-2021-03903
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867301832
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8973-01, 052029 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT ONE OF THE PRONGS INTENDED TO HOLD THE IMPLANT AT THE DISTAL TIP OF THE HUB ATTACHMENT TUBE HAD BROKEN. NO FRAGMENTS WERE RETURNED FOR ANALYSIS. THE WIDTH OF THE HUB ATTACHMENT TUBE PROXIMAL TO THE BREAKAGE SITE WAS ASSESSED USING DIGITAL MICROMETER ID: 224 AND WAS FOUND TO MEET DESIGN SPECIFICATIONS. THE CAUSE REMAINS UNDETERMINED, ALTHOUGH A PROBABLE CAUSE CAN BE ATTRIBUTED TO USER APPLIED MECHANICAL FORCES DURING USE WITH OTHER INSTRUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2021 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 TARGETING GUIDE "TOP OF THE SHAFT BROKEN OFF THE INSTRUMENT". THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663236 OUTRIGGER TARGETING GUIDE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. OUTRIGGER TARGETING GUIDE 052029 00888867301832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown