BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM X 110MM THREADED HIP CANNULA

    MDR report key: 4932937 · Received July 22, 2015

    Report

    Report Number
    1219602-2015-00402
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    July 21, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THE EVENT IS UNKNOWN AT THIS TIME. (B)(6). SUBJECT DEVICE(S) WERE RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMS THAT PIECES OF THE SILICONE MATERIAL WERE TORN FROM THE DEVICE, BUT THOSE PIECES WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DOES NOT IDENTIFY ANY DISCREPANCIES. A REVIEW OF THE DEVICE HISTORY REPORT(S) DID NOT IDENTIFY ANY DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY CONFIRMED THAT NO ADDITIONAL COMPLAINTS WERE ASSOCIATED WITH THE MANUFACTURED LOT ON FILE FOR THE REPORTED FAILURE MODE. PER RESULTS OF THE INVESTIGATION, ¿NO ROOT CAUSE COULD BE FOUND AFTER EVALUATION¿. AT THIS TIME, NO FURTHER INVESTIGATION WILL BE IMPLEMENTED. (B)(4).

    Description of Event or Problem · 1

    DURING A HIP ARTHROSCOPY, LABRAL REPAIR PROCEDURE UTILIZING THE 8.5MM X 110MM THREADED HIP CANNULA SYSTEM, IT WAS REPORTED THAT SMALL PIECES OF THE MEMBRANE HAVE FALLEN OFF WHILE INSERTING THE DEVICE. THE SURGEON REMOVED THE DEBRIS WITH AND ALLIGATOR MAX GRASPER. BACKUP DEVICE WAS AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT NO PIECES OF MEMBRANE WERE LEFT INSIDE OF THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477086 8.5MM X 110MM THREADED HIP CANNULA ACCESSORIES, ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50363011

    Patients

    Seq Age Sex Outcome Treatment
    1