BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN STRAIGHT MENISCAL REPAIR DEVICE

    MDR report key: 2297262 · Received October 15, 2011

    Report

    Report Number
    1825034-2011-00915
    Event Type
    Injury
    Date Received
    October 15, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 19, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO LOTS OF MAXFIRE MARXMEN STRAIGHT WERE USED DURING THIS PROCEDURE. THE INFORMATION FOR THE SECOND MENISCAL REPAIR DEVICE IS AS FOLLOWS: PART: 900320, LOT: 986330, MANUFACTURE DATE: 03/16/2011, EXPIRATION DATE: 02/28/2016. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF RETURNED DEVICE FOUND EVIDENCE OF INSERTION AT AN 18MM DEPTH. DEVICE INTENDED TO BE INSERTED WITH A DEPTH GAUGE OF 10MM. EVALUATION OF SECOND DEVICE WAS INCONCLUSIVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MENISCAL REPAIR PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE MENISCAL REPAIR DEVICE WOULD NOT REACH THE BACK OF THE MENISCUS AND PULLED OUT OF THE MENISCUS UPON REMOVAL OF THE INSERTER. TWO MENISCAL REPAIR DEVICES WERE ATTEMPTED FOR USE, BUT NEITHER DEVICE COULD BE FULLY IMPLEMENTED. AN ANCHOR FROM ONE OF THE MENISCAL REPAIR DEVICES REMAINS IMPLANTED.

    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 N/A 780030

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S