BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECON TARGETING ARM

    MDR report key: 2202666 · Received August 11, 2011

    Report

    Report Number
    1825034-2011-00707
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BIOMET TRAUMA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED.CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE.THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT FEMORAL RECONSTRUCTION SURGERY ON (B)(6), 2011. DURING THE PROCEDURE, THE SURGEON USED A TARGETING ARM TO VERIFY POSITIONING OF THE PROXIMAL SCREWS SO THAT THEY WOULD PASS THROUGH THE ANTEGRADE NAIL AND HOLD THE NAIL IN PLACE. THE PROXIMAL SCREWS MISSED THE ANTEGRADE NAIL, RESULTING IN A SIGNIFICANT DELAY OF THREE HOURS BEFORE COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECON TARGETING ARM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET TRAUMA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R