BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM

    MDR report key: 6693194 · Received July 7, 2017

    Report

    Report Number
    0002936485-2017-00660
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 9, 2017
    Report Date
    July 7, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLEGED FAILURE: PIECE OF FLOWPORT POLYMER BROKE OFF IN INTO HIP JOINT SPACE. PROBABLE ROOT CAUSE: DESIGN: - INADEQUATE MATERIAL SELECTION TO SUPPORT MOVEMENT/MANIPULATION BY USER, - CANNULA TUBING THICKNESS TOO SMALL TO SUPPORT MOVEMENT/MANIPULATION BY USER, - CANNULA SIZE OR GEOMETRY DOES NOT PROMOTE PROPER VISUALIZATION OF JOINT, - EXCESSIVELY SHARP TIP OF CANNULA DAMAGES TISSUE, MANUFACTURING: - CANNULA NOT ASSEMBLED, MOLDED OR MACHINED TO SPECIFICATION, APPLICATION: - EXCESSIVE FORCE, - POOR VISUALIZATION THROUGH ARTHROSCOPE. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL END BROKE OFF INTO THE HIP JOINT SPACE. THE BROKEN PIECE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474920 FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM ACCESSORIES,ARTHROSCOPIC NBH STRYKER ENDOSCOPY-SAN JOSE 16103101

    Patients

    Seq Age Sex Outcome Treatment
    1