BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE MARXMEN - STRAIGHT MENISCAL REPAIR DEVICE

    MDR report key: 1920297 · Received December 10, 2010

    Report

    Report Number
    1825034-2010-00651
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OF LOT 714100 WERE ATTEMPTED FOR USE DURING THE PROCEDURE. HOWEVER, ONLY ONE UNIT WAS RETURNED FOR EVALUATION. OTHER- EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. 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. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. 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. THIS REPORT SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING MENISCAL REPAIR DEVICES ON (B)(6) 2010. DURING THE PROCEDURE, THE TRIGGER ON FOUR DIFFERENT DEVICES WOULD STICK AND THE ANCHORS WOULD NOT DEPLOY. A COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE MARXMEN - STRAIGHT MENISCAL REPAIR DEVICE STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE, INC. N/A 714100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R