BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSTITCH SUTURING DEVICE

    MDR report key: 3201976 · Received June 27, 2013

    Report

    Report Number
    3006524618-2013-00254
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GAT
    PMA / PMN Number
    K042031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE USING A SPEEDSTITCH SUTURING DEVICE, THE NEEDLE BECAME JAMMED IN THE HANDLE, PREVENTING THE DEVICE FROM WORKING PROPERLY. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293013 SPEEDSTITCH SUTURING DEVICE SUTURE UNITS GAT ARTHROCARE CORPORATION H897000

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other