BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUTURELASSO, 90 DEGREE STRAIGHT

    MDR report key: 1081165 · Received July 1, 2008

    Report

    Report Number
    1220246-2008-00116
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    March 13, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. REVIEW OF THE DEVICE HISTORY REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX 1 INCH OF THE METAL CURVED END OF THE DEVICE BROKE OFF DURING SURGERY AND BECAME LODGED IN THE TISSUE NEAR THE LEFT SHOULDER. THE PT WAS UNDERGOING AN ARTHROSCOPIC REPAIR OF A LABRAL TEAR. THE PIECE WAS RETRIEVED BUT THE SURGERY WAS DELAYED APPROX 1 HR. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L 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 SUTURELASSO, 90 DEGREE STRAIGHT SUTURE PASSER HWQ ARTHREX, INC. NA 729915521

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other