BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE WITH ZIPLOOP

    MDR report key: 2180015 · Received July 27, 2011

    Report

    Report Number
    1825034-2011-00645
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED DEVICE FOUND THAT IT FUNCTIONS PROPERLY AND BOTH TRIGGERS SLIDE EASILY. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2011-00642 / 00645). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING MENISCAL REPAIR DEVICES ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY DEPLOYING FIVE DEVICES THAT WERE ATTEMPTED FOR USE. THE PROCEDURE WAS COMPLETED WITHOUT INJURY TO THE PATIENT OR SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE WITH ZIPLOOP STAPLE, FIXATION JDR BIOMET SPORTS MEDICINE N/A 400810

    Patients

    Seq Age Sex Outcome Treatment
    1