BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC WRIST TOWER UPPER ARC

    MDR report key: 8301473 · Received February 4, 2019

    Report

    Report Number
    3025141-2019-00100
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 10, 2019
    Report Date
    January 10, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HST
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT EXAMINED VISUALLY UNDER MAGNIFICATION. ALL THREADED FEATURES WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. WELDS CONNECTING THE ARM SLEEVES TO THE LOCKING JOINT HAVE CRACKED. ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2019-00097: ROSETTE KNOB 1, 3025141-2019-00098: ROSETTE KNOB 2, 3025141-2019-00099: TOWER WRIST JOINT.

    Description of Event or Problem · 1

    DURING SURGERY ON THE PATIENT'S ARM, IT WAS SUPPORTED BY THE ARC WRIST TOWER. DURING THE SURGERY, THE SURGEON FOUND TINY METAL FLAKES IN THE WOUND. THE FLAKES WERE COMING FROM THE ARC WRIST TOWER. ALL OF THE METAL FLAKES WERE NOT SUCCESSFULLY REMOVED FROM THE WOUND, AS SOME WERE STICKING TO THE SYNOVIUM EVEN WHEN WASHED THOROUGHLY. THERE WAS A DELAY IN SURGERY AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95126 ARC WRIST TOWER UPPER ARC APPARATUS, TRACTION, NON-POWERED HST ACUMED LLC 10100015 331081

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention