BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECON TARGETING ARM

    MDR report key: 3230194 · Received July 16, 2013

    Report

    Report Number
    0001825034-2013-02721
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAMEDULLARY FEMORAL NAIL PROCEDURE, THE JIG REPORTEDLY MISTARGETED WHILE INSERTING THE RECONSTRUCTIVE SCREWS INTO THE ANTEGRADE NAIL. SURGEON COMPLETED THE PROCEDURE FREE-HAND. THERE WAS A THIRTY-FIVE (35) MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328578 RECON TARGETING ARM GENERAL, MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 306100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R