BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SINGLE LOADED SIZE 1 BLUE / WHITE MAXBRAID

    MDR report key: 2061591 · Received April 18, 2011

    Report

    Report Number
    1825034-2011-00281
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    MBI
    PMA / PMN Number
    K071704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES,"BENDING OR FRACTURE OF THE IMPLANT". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED APRIL 18, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LABRAL REPAIR (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON IMPLANTED A SUTURE ANCHOR. AS THE SURGEON WAS USING A COMPETITOR'S KNOT PUSHER TO PUSH DOWN THE SECOND KNOT, THE SUTURE BROKE. THE ANCHOR OF THE SUTURE ANCHOR REMAINS IMPLANTED. A COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUGGERKNOT SINGLE LOADED SIZE 1 BLUE / WHITE MAXBRAID FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE, INC. N/A 614980

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S