BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 19770839 · Received July 18, 2024

    Report

    Report Number
    1220246-2024-06805
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028645
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 1268-100 RADIOLUCENT TARGETING ARM BATCH NUMBER: 210929 WAS RECEIVED FOR INVESTIGATION. THE 1268-100 RADIOLUCENT TARGETING ARM WAS RECEIVED WITH AN 0826-000 IMPACTOR PAD BATCH NUMBER: 211082 ATTACHED TO IT. VISUAL INSPECTION OF THE RETURNED DEVICES NOTED THAT THE 0826-000 IMPACTOR PAD WAS STUCK TO THE GROMMET OF THE 1268-100 RADIOLUCENT TARGETING ARM AND COULD NOT BE DETACHED. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE DEVICES BEING UNABLE TO BE SEPARATED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO EXCESSIVE MECHANICAL FORCES BEING APPLIED TO THE IMPACTOR PAD.

    Description of Event or Problem · 0

    ON 6/25/2024, A SALES REPRESENTATIVE VIA SEMS(B)(4) REPORTED THAT A 1268-100 RADIOLUCENT TARGETING ARM, 130 DEGREE TROCH NAIL HAD AN ISSUE. THE INSIDE SCREW THAT ACCEPTS THE 0826-000 IMPACTOR PAD CAME OUT OF THE ACTUAL JIG ITSELF AND IS ATTACHED TO THE IMPACTOR PAD AND WILL NOT COME LOOSE. THE PATIENT WAS NOT HARMED. A PHOTO IS PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150367 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 210929 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown