BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUTURESNARE, 15 DEGREE

    MDR report key: 1083573 · Received July 24, 2008

    Report

    Report Number
    1220246-2008-00140
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE CUSTOMER'S COMPLAINT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE CAUSE OF THE COMPLAINANT'S EVENT, HOWEVER, COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD PASSED THE FIBERLINK WITH THE SUTURESNARE THROUGH THE LABRUM AND WHEN TRYING TO RETRIEVE IT, THE SUTURESNARE TIP BECAME STUCK AND BROKE AS HE PULLED IT OUT. X-RAYS CONFIRMED THE TIP REMAINS INSIDE THE TISSUE. SHOULDER ARTHROSCOPY, LABRUM REPAIR. NO FURTHER PT INFO IS AVAILABLE AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURESNARE, 15 DEGREE SUTURE PASSER GAB ARTHREX, INC. NA 121521

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other