BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDPASS DISPOSABLE SUTURE LARIAT W/NITINOL WIRE

    MDR report key: 2112090 · Received June 2, 2011

    Report

    Report Number
    1825034-2011-00474
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED FRACTURED TIP FOUND ABRASIONS AND SIGNS OF WEAR ON THE EXTERIOR AND THE TIP APPEARS SHARP. THE FRACTURE END SHOWS AN AREA WHERE A THIN FLAP OF METAL REMAINS. THE FRACTURE ARTIFACTS SUGGEST A BENDING OVERLOAD. THIS REPORT FILED (B)(6), 2011.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A SUTURE RETRIEVER ON (B)(6) 2011. DURING THE PROCEDURE, THE TIP FRACTURED WHILE THE SURGEON WAS ATTEMPTING TO PENETRATE THE LABRUM. THE SURGEON WAS ABLE TO RETRIEVE THE FRACTURED PIECE. THERE WAS NO INJURY TO THE PATIENT OR SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDPASS DISPOSABLE SUTURE LARIAT W/NITINOL WIRE MANUAL SURGICAL INSTRUMENT MDM BIOMET SPORTS MEDICINE N/A 276850

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R