BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX SUTURETAK

    MDR report key: 2153250 · Received June 30, 2011

    Report

    Report Number
    MW5021240
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SINGLE USE PERCUTANEOUS CANNULA KIT WAS OPENED DURING SURGERY. UPON SEQUENTIAL USE OF PERCUTANEOUS DILATOR PRODUCTS WITHIN THE KIT, IT WAS DISCOVERED THAT A "DISTATSEN NEEDLE WITH STYLET 17 GA" WAS IN FACT ONLY THE STYLET, PROMPTING ALTERNATIVE ACTIONS ON THE PART OF THE SURGICAL TEAM AND PROLONGING OPERATIVE TIME APPROX 10 MINS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX SUTURETAK PERCUTANEOUS INSERTION DISPOSABLE KIT MAI ARTHREX, INC. 381535

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other