BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR PAD

    MDR report key: 23943465 · Received January 2, 2026

    Report

    Report Number
    1220246-2026-00010
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 11, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665002805
    PMA / PMN Number
    K132005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    ADDITIONAL INFORMATION: D9, G3, H3, H6 ONE UNPACKAGED 0826-000, IMPACTOR PAD, BATCH 210508, WAS RECEIVED STUCK TO A 1267-100 RADIOLUCENT TARGETING ARM (BATCH 212569) . VISUAL INSPECTION NOTED THAT THE 0826-000 IMPACTOR PAD WAS STUCK TO THE GROMMET OF THE 1267-100 RADIOLUCENT TARGETING ARM AND COULD NOT BE DETACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICES WERE INSEPARABLE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO USE-RELATED FACTORS, INCLUDING WEAR-AND-TEAR DAMAGE AND EXCESSIVE MECHANICAL FORCES APPLIED TO THE IMPACTOR PAD IN THE FIELD OVER TIME. THE MANUFACTURING DATE FOR THE TARGETING ARM IS NOVEMBER 2021. REFER TO THE INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 11-DEC-2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN 0826-000 IMPACTOR PAD BROKE WHILE THE SURGEON WAS TRYING TO REMOVE IT TO GET BETTER VISUALIZATION ON THE LATERAL X-RAY TO VERIFY PIN PLACEMENT DURING A CASE. THERE WERE NO ADVERSE EVENTS, AND THE CASE WAS FINISHED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9807 IMPACTOR PAD INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. IMPACTOR PAD 210508 00848665002805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown