BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR PAD

    MDR report key: 24178209 · Received January 26, 2026

    Report

    Report Number
    1220246-2026-00313
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 9, 2026
    Report Date
    March 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665002805
    PMA / PMN Number
    K132005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 220991, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED MULTIPLE FORMS OF DAMAGE, INCLUDING: SURFACE DAMAGE IMPACTOR PAD STRIPPED THREADS CHIPPING DISCOLORATION FUNCTIONAL TESTING NOTED RESISTANCE WHEN LOCKING AND UNLOCKING INTO A KNOWN-GOOD TARGETING ARM. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER TIME. THE MANUFACTURING DATE IS 2022. THE COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE INVESTIGATION PHOTOGRAPHS.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT THE 0826-000 IMPACTOR PAD BECAME COLD-WELDED TO THE 1268-100 130-DEGREE RADIOLUCENT TARGETING ARM, AND UPON REMOVAL, THE METAL FITTING INSIDE THE TARGETING ARM CAME OUT WITH THE IMPACTOR PAD, RENDERING BOTH UNUSABLE. THE DAMAGE THAT WAS INCURRED PERHAPS ADDED 5 MINUTES ONTO THE CASE AND ADDITIONAL ANESTHESIA, BUT NO DIRECT HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241163 IMPACTOR PAD INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. IMPACTOR PAD 220991 00848665002805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown