BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE VANGUARD SLIDEX FEMORAL BLOCK

    MDR report key: 1213165 · Received October 29, 2008

    Report

    Report Number
    1825034-2008-00287
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Report Date
    October 3, 2008
    Manufacturer
    BIOMET INC.
    Product Code
    IQO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1825034-12/23/08-013-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE CONFIRMED REPORTED CONDITION. IN RESPONSE TO REPORTED EVENT, HEALTH HAZARD EVALUATION WAS CONDUCTED AND RECALL WAS INITIATED TO REWORK THE INSTRUMENTS. THIS REPORT FILED JANUARY 23, 2009

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. EVENT DATE: 2008. EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2008. DURING PROCEDURE, PIN FROM CUTTING BLOCK FELL OUT OF THE BLOCK AND INTO THE PATIENT'S WOUND. PIN WAS RETRIEVED FROM PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE 2008. DURING PROCEDURE, PIN FROM CUTTING BLOCK FELL OUT OF THE BLOCK AND INTO THE PATIENTS WOUND. PIN WAS RETRIEVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE VANGUARD SLIDEX FEMORAL BLOCK INSTRUMENT, ALIGNMENT DEVICE IQO BIOMET INC. N/A 132502

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R