BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMAN - STRAIGHT

    MDR report key: 1823141 · Received September 1, 2010

    Report

    Report Number
    1825034-2010-00353
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE PROCEDURE UTILIZING A MAXFIRE MAR ON (B)(6) 2010. THE SURGEON ATTEMPTED TO USE THE MAXFIRE MARXMEN IN THE PATIENT'S KNEE, BUT THE TRIGGER WOULD NOT DEPRESS. ANOTHER MAXFIRE MARXMEN WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMAN - STRAIGHT STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE, INC. N/A 702870

    Patients

    Seq Age Sex Outcome Treatment
    1