BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV

    MDR report key: 5224315 · Received November 15, 2015

    Report

    Report Number
    1219602-2015-01175
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Date of Event
    August 6, 2014
    Report Date
    August 14, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ONE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS FUNCTIONALLY TESTED VIA LEAK TEST PER 1200904 INSPECTION PROCEDURE FOR IRRIGATION EXTENDERS AND CANNULAS. THE DEVICE DID NOT PASS SPECIFICATION REQUIREMENTS. THE DEVICE WAS CONFIRMED TO BE LEAKING AT THE LOCATION OF THE ROTATING RING AND THE INSERTION LOCATION OF THE VALVES. THE FAILURE MODE IS CONFIRMED. THE DEVICE WAS VISUALLY EVALUATED AND A GAP BETWEEN THE ROTATOR RING AND THE CANNULA BODY WAS IDENTIFIED, INDICATING THAT THE PRESS FIT OF THE UNIT HAS BEEN COMPROMISED. THIS IS DUE TO EXCESSIVE FORCE THAT WAS PLACED ON THE UNIT AND A RESULT THE INTERFACE BETWEEN THE COMPONENTS HAS BEEN LOOSENED ALLOWING WATER TO SEEP IN BETWEEN. THE PARTS WERE MANUFACTURED 03/2014. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE.

    Description of Event or Problem · 1

    LEAKING JAPAN REF. (B)(4): DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION USING THE CANN, H.F., DGNST, 6MM, RTBL, DBL VLV IT WAS REPORTED THAT FLUID LEAKAGE WAS OCCURRED. THE OPERATION WAS COMPLETED WITH THIS DEVICE. AFTER THE INCIDENT, THE DEVICE WAS CHECKED WITH THE CONICAL OBTURATOR (C/N: 4356) AT SNEKK. THE DEFECT WAS CONFIRMED. THE LEAKAGE OCCURRED AROUND THE ROTATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754398 CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 50495690

    Patients

    Seq Age Sex Outcome Treatment
    1