BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SINGLE LOADED SIZE 1

    MDR report key: 2220920 · Received August 23, 2011

    Report

    Report Number
    1825034-2011-00747
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    K071704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "DO NOT USE EXCESSIVE FORCE WHEN INSERTING THE DEVICE. EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE DEVICE AND/OR ADVERSELY AFFECT ITS PERFORMANCE." THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ARTHROSCOPIC LABRAL PROCEDURE UTILIZING A SOFT TISSUE ANCHOR DEVICE ON (B)(6), 2011. DURING THE PROCEDURE, THE TIP OF THE DEVICE FRACTURED UPON INSERTION AND THE SURGEON FELT THE PATIENT RETAINED THE FRACTURED PIECE; HOWEVER, THE FRAGMENT DID NOT APPEAR ON RADIOGRAPH DUE TO IT'S SMALL SIZE. THE SURGEON PLANS TO TAKE A CT OR MRI SCAN TO CONFIRM THE LOCATION OF THE FRAGMENT AT SOME POINT IN THE FUTURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUGGERKNOT SINGLE LOADED SIZE 1 FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE N/A 195220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S