BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER

    MDR report key: 6710086 · Received July 13, 2017

    Report

    Report Number
    1043534-2017-00076
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 15, 2017
    Report Date
    June 15, 2017
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXR
    PMA / PMN Number
    K853438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE TENDON ROD WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMS THAT THE DEVICE HAS FRACTURED AT THE SUTURED END OF THE ROD. ALSO VISUAL EXAMINATION SHOWS THAT THE SUTURE HAD NOT BEEN PASSED THROUGH THE POLYESTER CORE WHICH INDICATES THAT THE SUTURE WAS NOT PASSED THROUGH THE POLYESTER TAPE CORE INITIALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. SOMETIME POST-OP THE TENDON ROD RUPTURED. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE TENDON ROD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491799 HUNTER SPATULA, ORTHOPEDIC HXR WRIGHT MEDICAL TECHNOLOGY, INC. TR300000 1594606

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention