BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE IMPACTOR, ASSEMBLY

    MDR report key: 22509899 · Received July 15, 2025

    Report

    Report Number
    1220246-2025-02883
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 18, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867136731
    PMA / PMN Number
    EXEMPT
    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 AR-9165CDG, UNIVERSAL BASEPLATE IMPACTOR, BATCH NUMBER: 052332 WAS RECEIVED FOR INVESTIGATION. - VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE BLUE ADAPTER WAS BROKEN. - 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 OF THE DEVICE DUE TO APPLYING EXCESSIVE MECHANICAL FORCES DURING IMPACTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE. - REFER TO INVESTIGATION PHOTOS. - COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 06/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9165CDG BASE PLATE IMPACTOR'S BLUE CLIP IS BROKEN. NOTICED DURING A CASE AND CASE COMPLETED WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771829 BASEPLATE IMPACTOR, ASSEMBLY ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. BASEPLATE IMPACTOR, ASSEMBLY 052332 00888867136731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown