BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PLANNER; SIGNATURE GUIDES

    MDR report key: 2999872 · Received March 8, 2013

    Report

    Report Number
    3003998208-2013-00003
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MATERIALISE N.V.
    Product Code
    JWH
    PMA / PMN Number
    K102795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INTERNAL DOCUMENTATION AND THE ACTUAL GUIDE IS IN PROGRESS. A F/U REPORT WILL BE FILED WHEN THE ROOT CAUSE INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE UTILIZING SIGNATURE PT SPECIFIC INSTRUMENTS GUIDES. AFTER THE CUTS WERE MADE A NOTCH IN THE ANTERIOR CUT OF THE FEMUR WAS DETECTED WHICH CAUSED THE FEMUR TO FRACTURE. THE SURGEON ALSO REPORTED THE FEMUR IMPLANT SIZE DID NOT MATCH THE PLANNED SIZE. A DISTAL FEMORAL PLATE WAS USED TO STABILIZE THE FRACTURE. THIS RESULTED IN A DELAY DURING SURGERY OF MORE THAN 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99710 SIGNATURE PLANNER; SIGNATURE GUIDES JWH MATERIALISE N.V. 42-422561 070059

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening