BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE KNEE GUIDES 04-05

    MDR report key: 2883836 · Received December 21, 2012

    Report

    Report Number
    0001825034-2012-02600
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK102795
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PLANNING AND PROCEDURES FOUND THE TIBIAL GUIDE WAS DESIGNED ACCORDING TO THE CORRECT SPECIFICATIONS. NO ROOT CAUSE COULD BE FOUND.

    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. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING A SIGNATURE TIBIAL GUIDE ON (B)(6) 2012. WHEN THE SURGEON ATTEMPTED TO REMOVE THE GUIDE, THE DRILL BIT WAS STUCK IN THE GUIDE CAUSING PIECES TO FALL INTO THE WOUND. THE SURGEON RETRIEVED THE PIECES AND USED ANOTHER DRILL BIT TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE KNEE GUIDES 04-05 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 064180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R