BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN STRAIGHT

    MDR report key: 4217566 · Received October 31, 2014

    Report

    Report Number
    0001825034-2014-08461
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK111564
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION - THIS REPORT IS BEING SUBMITTED FOR TWO MAXFIRE MARXMEN DEVICES, PART 900320, LOT 794000. DEVICE AVAILABILITY: THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. INITIAL REPORTER PHONE: (B)(6). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 4 OF 5 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08458 / 08462).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE ON (B)(6) 2014, THE MENISCAL REPAIR DEVICE DEPLOYMENT MECHANISM DID NOT FUNCTION PROPERLY TO ENABLE IT TO ANCHOR AT THE POSTERIOR END OF THE MENISCUS. THIS HAPPENED WITH MULTIPLE DEVICES. A DELAY OF TWO HOURS OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700352 MAXFIRE MARXMEN STRAIGHT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET ORTHOPEDICS N/A 794000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention