BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.5MM 1 #2 MB

    MDR report key: 3994142 · Received August 8, 2014

    Report

    Report Number
    0001825034-2014-06938
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WARNINGS, NUMBER 2 STATES," IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE DEVICE CAN LEAD TO FAILURE OF THE DEVICE OR THE PROCEDURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LABRAL REPAIR PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE SUTURE ANCHOR WOULD NOT ENGAGE WITH THE DRILL HOLE. ANOTHER HOLE WAS DRILLED AND A NEW SUTURE ANCHOR WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472300 JUGGERKNOT 1.5MM 1 #2 MB FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 324660

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention