BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGRKNOT 2.9MM 2 #2MB BLUE

    MDR report key: 3011304 · Received March 19, 2013

    Report

    Report Number
    0001825034-2013-00645
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. "THE PATIENT IS TO BE MADE FULLY AWARE AND WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE, AND THAT THE DEVICE CAN BREAK OR BE DAMAGED AS A RESULT OF STRESS, ACTIVITY, LOAD BEARING, OR WEIGHT BEARING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, A PROCEDURE TO REPAIR THE PATIENT'S ROTATOR CUFF WAS PERFORMED ON (B)(6)2013. DURING THE PROCEDURE, THE ALREADY IMPLANTED SOFT ANCHOR CAME OUT AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114563 JUGGRKNOT 2.9MM 2 #2MB BLUE FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE N/A 513010

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R