BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN - CURVED

    MDR report key: 1840411 · Received September 21, 2010

    Report

    Report Number
    1825034-2010-00385
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE CONFIRMED REPORTED CONDITION.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A MENISCAL REPAIR DEVICE ON (B)(6) 2010. WHEN THE SURGEON ATTEMPTED TO DEPLOY THE SUTURE FROM THE GUN, THE TRIGGER WOULD NOT DEPRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMEN - CURVED STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE, INC. N/A 292710

    Patients

    Seq Age Sex Outcome Treatment
    1