BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN STRAIGHT MENISCAL REPAIR DEVICE

    MDR report key: 1875186 · Received October 19, 2010

    Report

    Report Number
    1825034-2010-00436
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE
    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

    THIS REPORT FILED OCTOBER 19, 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A MENISCAL REPAIR DEVICE ON (B)(6) 2010. DURING THE PROCEDURE, THE SECOND ANCHOR WOULD NOT DEPLOY WHEN THE TRIGGER WAS PULLED. ANOTHER DEVICE 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 MARXMEN STRAIGHT MENISCAL REPAIR DEVICE STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE N/A 249600

    Patients

    Seq Age Sex Outcome Treatment
    1