BLUEPRINT SOFTWARE

Description of Event or Problem

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

Additional Manufacturer Narrative

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

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. H3 OTHER TEXT : DEVICE DISPOSITION UNKNOWN.

Description of Event or Problem

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