BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUEPRINT SOFTWARE

    MDR report key: 19067681 · Received April 8, 2024

    Report

    Report Number
    3000931034-2024-00198
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    June 23, 2022
    Report Date
    July 16, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QHE
    PMA / PMN Number
    K232265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. BLUEPRINT TEAM FOUND THAT THIS CASE HAS BEEN PLANNED USING INCOMPATIBLE COMPONENTS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A DESIGN SOFTWARE RELATED ISSUE. SOME INCOMPATIBILITIES BETWEEN THE ANATOMIC GLENOID IMPLANTS PERFORM / PERFORM AUGMENTED AND THE ANATOMIC HUMERAL IMPLANT TORNIER FLEX ARE NOT MANAGED IN BLUEPRINT AND ALLOW THE SURGEON TO PLAN USING A CONFIGURATION OF THE IMPLANTS THAT IS NOT APPROVED. THE BUG IS PRESENT IN ALL VERSIONS OF THE SOFTWARE WHICH INCLUDE THE TORNIER FLEX IMPLANT. THE SPECIFIC CONFIGURATION OF THE TORNIER FLEX IMPLANT IS ONLY AVAILABLE IN THE US, AND HAS BEEN SINCE VERSION #2.1.4 PUBLISHED ON 02/03/2018 IN THE US. AN UPDATE RELATED TO THIS COMPLAINT WAS PERFORMED FOR SOFTWARE BLUEPRINT VERSION # 4.1.1. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN

    Description of Event or Problem · 0

    AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS".

    Description of Event or Problem · 0

    AS REPORTED: "BLUEPRINT SOFTWARE ALLOWED USERS TO PLAN SURGERIES USING INCOMPATIBLE (NOT APPROVED) CONFIGURATIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104247 BLUEPRINT SOFTWARE SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM QHE TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown