Investigation revealed that there was no system malfunction.The purpose of this investigation is to evaluate the risk associated with the identified failure mode of "navigational integrity" for the excel-siusgps.Investigation of the case logs showed that the patient registration contained a pre-operative merge shift.The preoperative merge can be more difficult depending on the quality of the preoperative ct scan, quality of the fluoroscopic images and patient anatomy.Preoperative merge shifts can cause navigational integrity and can lead to the misplacement of implants.The user must verify the preoperative merge before proceeding with navigation.Additionally, the user acknowledges that they will perform an anatomical landmark check to ensure navigational integrity before proceeding with navigation.The anticipated overall risk level is low.This is equal to the anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.The cause of the reported issue was traced to user technique.
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