BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    125° RADIOLUCENT TARGETING ARM

    MDR report key: 19734083 · Received July 12, 2024

    Report

    Report Number
    1220246-2024-06727
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 11, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028652
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 1267-100 RADIOLUCENT TARGETING ARM LOT NUMBER: 212569 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE DEVICE WAS MISSING THE GROMMET WHERE THE IMPACTOR PAD ATTACHES. IT WAS NOTED THAT THE GROMMET WAS RECEIVED STUCK TO THE 0826-000 IMPACTOR PAD BATCH NUMBER: 220991. 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 EXCESSIVE MECHANICAL FORCES BEING APPLIED TO THE IMPACTOR PAD AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1267-100 RADIOLUCENT TARGETING ARMS IMPACTOR PAD BROKE OUT OF THE JIG. THE ATTACHMENT FROM THE JIG IS STUCK ON AN 0826-000 IMPACTOR ROD. THIS OCCURRED DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862431 125° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 125° RADIOLUCENT TARGETING ARM 212569 00848665028652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown