BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE

    MDR report key: 6157915 · Received December 9, 2016

    Report

    Report Number
    1043534-2016-00121
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 17, 2016
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 45750001, 510K #K140148 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT A HAMMER TOE WITH INSERTING A K-WIRE. THE OPERATION WENT WITHOUT COMPLICATION. THE PATIENT WORE A DRESSING SHOE POSTOPERATIVELY. APPROXIMATELY 4 YEARS POST-OP, THE PATIENT EXPERIENCED STRONG PAIN. AN X-RAY EXAMINATION SHOWED THAT THE IMPLANT WAS BROKEN INTO TWO PARTS. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE FRONT FRAGMENT OF THE K-WIRE. THE PATIENT'S PAIN SUBSIDED BUT DID NOT DISAPPEAR. AS A RESULT, IT WAS FOUND THAT THE SECOND FRAGMENT WAS MIGRATING IN THE BONE AND THEREFORE THE SECOND PIECE OF THE K-WIRE HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812776 K-WIRE SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. DC2228316 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention