BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWANSON HUNTER ROD SIZER SET

    MDR report key: 5771222 · Received July 5, 2016

    Report

    Report Number
    1043534-2016-00064
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Date of Event
    April 29, 2016
    Report Date
    July 5, 2016
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS CONSIDERED CLOSED. IF AT ANY TIME NEW OR UPDATED INFORMATION BECOMES AVAILABLE, THE INCIDENT WILL BE RE-OPENED AND INVESTIGATED.

    Description of Event or Problem · 1

    ALLEGEDLY, NON STERILE SPACER IS PACKAGED IN SIMILAR FASHION AS THE STERILE IMPLANT. THE WARNING THAT THE SPACERS ARE NOT STERILE IS IN VERY SMALL PRINT ON THE SIDE OF THE BOX AND CAN BE EASILY MISSED. BOTH BOXES ARE RED AND THE SAME SHAPE AND SIZE. REPORTED THROUGH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424342 SWANSON HUNTER ROD SIZER SET SMALL JOINTS INSTRUMENT HXA WRIGHT MEDICAL TECHNOLOGY, INC. 1574329

    Patients

    Seq Age Sex Outcome Treatment
    1