BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE WITH ZIPLOOP

    MDR report key: 1193136 · Received October 8, 2008

    Report

    Report Number
    2027970-2008-00031
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    July 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SURGEON'S SECOND TIME USING THE MAXFIRE PRODUCT. IT'S LIKELY THAT WHILE ADVANCING, THE SURGEON PULLED BACK ON THE INSERTER HANDLE ONCE IT WAS ENGAGED IN THE CANNULA. THIS STRIPPED THE ANCHOR OFF THE INSERTER ASSEMBLY CAUSING A PRE-DEPLOYMENT.

    Description of Event or Problem · 1

    DEVICE 1. THERE WERE A TOTAL OF FIVE DEVICES WITH A COMBINATION OF THREE SEPARATE LOTS USED IN THIS CASE. THE USER STATES THAT ALL THE DEVICE DEPLOYED PREMATURELY. NONE OF THE IMPLANTS WERE INSERTED IN THE PATIENT. SURGERY WAS EXTENDED APPROXIMATELY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE WITH ZIPLOOP JDR BIOMET SPORTS MEDICINE 900339 L987520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other