BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC WRIST TOWER UPPER ARC

    MDR report key: 24351647 · Received February 16, 2026

    Report

    Report Number
    3025141-2026-00106
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 16, 2026
    Manufacturer
    ACUMED, LLC
    Product Code
    HST
    UDI-DI
    10806378010095
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE. RELATED REPORTS (INCLUDING THIS REPORT): 3025141-2026-00107, 3025141-2026-00108, 3025141-2026-00109.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CROSS THREADING ON 2 SEPARATE ARC WRIST TOWERS, THE TOWER ARM AND TENSION KNOB GOT STUCK AND WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER ARC WRIST TOWER. A REPORTED DELAY OF 20 MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362845 ARC WRIST TOWER UPPER ARC APPARATUS, TRACTION, NON-POWERED HST ACUMED, LLC 10100015 10806378010095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other