BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAVEN SUTURE RETRIEVER

    MDR report key: 641672 · Received August 25, 2005

    Report

    Report Number
    9613278-2005-00015
    Event Type
    Other
    Date Received
    August 25, 2005
    Date of Event
    July 22, 2005
    Report Date
    August 23, 2005
    Manufacturer
    LINVATEC BIOMATERIALS, LTD.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PIERCING THE TISSUE TO CLOSE THE SUPERIOR INJURY OF THE ROTATOR CUFF WITH THE RAVEN SUTURE RETRIEVER, TO PULL THE SUTURE FROM THE OTHER PORTAL, WE OBSERVED IT DID NOT TAKE THE SUTURE, REMOVED IT TO VERIFY AND REALIZED THAT SUTURE RETRIEVER BROKE IN ITS SUPERIOR PART, REMAINING INSIDE PATIENT, AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAVEN SUTURE RETRIEVER REUSABLE, SURGICAL INSTRUMENT LXH LINVATEC BIOMATERIALS, LTD. GU1008 0449

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other