BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX¿

    MDR report key: 25160834 · Received May 13, 2026

    Report

    Report Number
    3012966183-2026-00005
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 13, 2026
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00196449011759
    PMA / PMN Number
    K253042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS EVALUATED AND INVESTIGATED WITH THE CURRENTLY AVAILABLE INFORMATION. THE IMPACTED DEVICE REMAINS IMPLANTED AND NOT AVAILABLE FOR RETURN; THEREFORE A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED FOR LOT RELATED NONCONFORMITIES, AS NO IDENTIFYING LOT INFORMATION WAS MADE AVAILABLE. A HISTORICAL DATA ANALYSIS IDENTIFIED NO TRENDS RELATED TO THE NATURE OF THIS EVENT. THE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A SCREW BROKE INSIDE OF THE CANAL. IT WAS A METACARPAL NAIL OUT OF THE MVX HAND SYSTEM. WE HAD TO TRY TO REMOVE THE NAIL WHICH WAS UNSUCCESSFUL. THERE WAS MORE BONE REMOVAL BECAUSE OF THE BROKEN NAIL. ADD ANOTHER HOUR AND A HALF TO THE CASE. NAIL HAD TO STAY IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611128 A.L.P.S. MVX¿ 3.0MM IM NAIL 50MM HWC TYBER MEDICAL 770300050 00196449011759

    Patients

    Seq Age Sex Outcome Treatment
    1