BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE SPRING DRILL PIN

    MDR report key: 2073143 · Received April 29, 2011

    Report

    Report Number
    1825034-2011-00315
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT FOUND THE PROXIMAL END HAS ANNULAR WEAR AROUND THE SHANK ON BOTH SIDES OF THE GROOVE TO THE END OF THE FLAT SECTION. THE DISTAL END HAS MACHINING MARKS WITH FEW SIGNS OF WEAR. THE THREAD SURFACES HAVE WHAT MAY BE CUTTING TOOL CHATTER. THE FRACTURE SURFACES ARE MOSTLY GRANULAR WITH EVIDENCE OF PLASTIC DEFORMATION. THE FRACTURE ARTIFACTS SUGGEST THE FRACTURE OCCURRED IN BENDING OVERLOAD. THIS REPORT FILED APRIL 29, 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, POST-OPERATIVE RADIOGRAPHS SHOWED THAT THE PIN HAD FRACTURED AND REMAINS IN THE PATIENT'S DISTAL FEMUR. THE SURGEON NOTIFIED THE PATIENT OF THE FRACTURED PIECE. TO DATE, NO REVISION PROCEDURE IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE SPRING DRILL PIN MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A 411020

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability