BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN - STRAIGHT MENISCAL REPAIR DEVICE

    MDR report key: 2032242 · Received March 29, 2011

    Report

    Report Number
    1825034-2011-00223
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE NEEDLE SLED WAS BENT AT THE 18MM MARK ON THE NEEDLE SLED, MEANING THE NEEDLE SLED WAS FULLY EXTENDED INSIDE THE JOINT SPACE. HOWEVER, THE SURGICAL TECHNIQUE SUGGESTS THAT THE MENISCUS SHOULD BE ENGAGED WHILE ONLY 10MM OF THE NEEDLE SLED IS EXPOSED. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING A MENISCAL REPAIR DEVICE ON (B)(6) 2011. DURING THE PROCEDURE, THE NEEDLE SLED OF THE DEVICE BENT IN THE PATIENT'S KNEE AND THE IMPLANT COULD NOT BE PLACED. THE SURGEON SHAVED OUT THE MENISCUS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMEN - STRAIGHT MENISCAL REPAIR DEVICE STAPLE, FIXATION, BONE JDR BIOMET SPORTS MEDICINE, INC. N/A 039620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R