BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR 2.9 W/ ULTRABRAID

    MDR report key: 1014079 · Received March 14, 2008

    Report

    Report Number
    1219602-2008-00062
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 19, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE ANCHOR WAS TAPPED IN AND THE SURGEON WAS SLIDING HIS FIRST KNOT DOWN WHEN SUTURE SNAPPED AT THE EYELET. REPAIR WAS COMPLETED USING A COMPETITOR'S DEVICE. IT IS CONFIRMED THAT THE ANCHOR WAS LEFT IN THE PT AFTER THE SUTURE SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR 2.9 W/ ULTRABRAID BIORAPTOR MBI SMITH & NEPHEW INC., ENDOSCOPY DIV. 72200775 50236619

    Patients

    Seq Age Sex Outcome Treatment
    1