BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X40MM

    MDR report key: 2821221 · Received November 6, 2012

    Report

    Report Number
    0001825034-2012-02364
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. EXAMINATION OF RETURNED DEVICE FOUND IT IS POSSIBLE THAT THE SCREWS WERE OVERTIGHTENED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02363 / 02364).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE THE SURGEON IMPLANTED THE TIBIAL BASE PLATE AND PROCEEDED TO INSERT THE SCREWS. AS THE SURGEON WAS DRILLING THE POSTERIOR SCREW AND TIGHTENING THE SCREW IT SLIPPED THROUGH THE BASEPLATE. SURGEON HAD TO DRILL A NEW HOLE AND THEN INSERTED NEW SCREWS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOW PROFILE SCREW 6.5X40MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 388650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R