BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE W/ZIPLOOP

    MDR report key: 2172178 · Received July 22, 2011

    Report

    Report Number
    1825034-2011-00593
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. TWO OF THIS LOT WERE USED DURING THE PROCEDURE. 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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    MDR 1825034-2011-00593 & 00594 WERE REPORTING THE SAME EVENT. EVALUATION OF RETURNED DEVICES USED IN THE PROCEDURE CONFIRMED 2 UNITS FUNCTIONED AS INTENDED AND ONE DEVICE HAD A LOOSE WELD AND WAS MISSING A COMPONENT. REVIEW OF DEVICE HISTORY RECORDS CONFIRMED THAT THE CORRECT COMPONENTS WERE ISSUED TO EACH DEVICE, AND THE WELD OPERATION WAS COMPLETED. REASON FOR THE RETURNED CONDITION COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON USED THREE MENISCAL REPAIR DEVICES. THE SWITCHES ON THE DEVICE THAT ARE USED TO DEPLOY AND CINCH THE ANCHORS WERE HARDER TO MOVE THAN EXPECTED. NO PATIENT INJURY OR SIGNIFICANT DELAY TO THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE W/ZIPLOOP STAPLE, FIXATION, BONE JDR BIOMET SPORTS MEDICINE, INC. N/A 590760

    Patients

    Seq Age Sex Outcome Treatment
    1