BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS II STEM IMPACTOR POINTED

    MDR report key: 21849468 · Received April 16, 2025

    Report

    Report Number
    1220246-2025-01491
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 27, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9202-09 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE BLUE HANDLE IS CRACKED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR. DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO IT, THE DEVICE WILL INEVITABLY SUSTAIN DAMAGE OVER TIME. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 03/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9202-09 IMPACTOR AND AN AR-9531 IMPACTOR BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122594 UNIVERS II STEM IMPACTOR POINTED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS II STEM IMPACTOR POINTED 022130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown