BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVR-DISTAL VOLAR RADIUS PLATE

    MDR report key: 1070731 · Received June 19, 2008

    Report

    Report Number
    1070731
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    April 28, 2008
    Report Date
    June 10, 2008
    Manufacturer
    HAND INNOVATIONS, LLC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE HOSPITAL FOR REPAIR OF A FRACTURED LEFT WRIST. THE OPERATION REQUIRED THE USE OF A PLATE WITH SEVEN (7) SCREWS TO STABILIZE THE FRACTURE. EACH SCREW HAS A GUIDE DEVICE USED TO DIRECT THE SCREW INTO THE BONE. AFTER THE SCREW IS INSERTED INTO THE BONE, THE GUIDE IS REMOVED. IT WAS DETERMINED THAT THIS PARTICULAR STYLE OF ORTHOPEDIC DEVICE WAS NOT FREQUENTLY USED BY OUR STAFF AND WAS DESIGNED TO HAVE SEPARATE FAST GUIDES WHEREAS OTHER SIMILAR DEVICES WERE DESIGNED WITH ALL OF THE FAST GUIDES CONNECTED TOGETHER SO THAT THEY WERE REMOVED AS A SET RATHER THAN INDIVIDUALLY. CONSEQUENTLY, THIS DEVICE REQUIRES A SEPARATE COUNT FOR EACH SCREW GUIDE WHILE THE MORE FREQUENTLY USED DEVICE REMOVES ALL OF THE SCREW GUIDES AT ONCE. THE OR STAFF WAS NOT AWARE OF THIS COUNTING REQUIREMENT WITH THIS DEVICE. A POST-OPERATIVE X-RAY WAS TAKEN TO VERIFY THE PLACEMENT OF THE PLATE. THE X-RAY REVEALED THE PRESENCE OF ONE OF THE SCREW GUIDES. THE PATIENT WAS TO RETURN TO THE OR AND THE GUIDE WAS REMOVED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVR-DISTAL VOLAR RADIUS PLATE PLATE, ORTHOPEDIC HRS HAND INNOVATIONS, LLC DVRA-A STANDARD LEFT PRODUCT *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR