BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXFIRE WITH ZIPLOOP

    MDR report key: 1080951 · Received July 23, 2008

    Report

    Report Number
    2027970-2008-00021
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    JDR
    PMA / PMN Number
    K061776
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY; HOSPITAL, WHILE ADVANCING THE SECOND ANCHOR (RED TRIGGER) THE USER SLIGHTLY RETRACTED IT TWICE. THIS STRIPPED THE ANCHOR OFF THE INSERTER ASSEMBLY CAUSING A PRE-DEPLOYMENT.

    Description of Event or Problem · 1

    TWO SEPARATE MAXFIRE SUTURE ANCHORS PREDEPLOYED THE SECOND IMPLANT WHILE INSERTING. THE FIRST IMPLANT WAS DETACHED FROM THE SECOND AND WAS NOT REMOVED FROM PT. THE IMPLANT LEFT BEHIND IS NOT SERVING ITS INTENDED PURPOSE. THE CASE WAS EXTENDED APPROX 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXFIRE WITH ZIPLOOP JDR BIOMET SPORTS MEDICINE 900339 L987500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other