BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 17810308 · Received September 25, 2023

    Report

    Report Number
    1220246-2023-07970
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 28, 2023
    Report Date
    November 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00848665010879
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKED 1267-000 125° RADIOLUCENT TARGETING ARM BATCH 130079 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE IMPACTOR PROTECTOR SILVER RING WAS MISSING. LASER MARKS ARE FADED. DAMAGE WAS OBSERVED ALL AROUND THE DEVICE. A FUNCTIONAL TEST WITH A TROCHANTERIC NAIL FOUND THE JIG MISALIGNED. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    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.

    Description of Event or Problem · 0

    ON 08/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06016727 THAT A 1267-000 TARGETING ARMS DISTAL HOLE ON THE JIG WAS NOT LINING UP ON THE SHORT NAIL. THIS OCCURRED DURING A HIP ORIF, WHERE THE DRILL WAS SKIVING ANTERIORLY. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743168 125° RADIOLUCENT TARGETING ARM INTRAMED FIXATN ROD AND ACCESS LXH ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 130079 00848665010879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown