It was reported that, during a tka surgery, while using the vis adpt guide kit jii, the femoral block was a poor fit.The patient's trochlear groove was not a good match with the block, the patient's anatomy was shallow compared to the cutting block.The doctor chose to remove a few osteophytes in order to try to get a better fit, but there was a significant anterior gap.Surgeon used the alignment guide and drop rod to confirm alignment was adequate.Surgeon made the visionaire guided femur cut, then took a +2mm distal recut.The anterior cut and rotation were adequate for the 5-in-1 cut.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.
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H3, h6: the device was not returned for evaluation.However, a review made by the quality engineering team revealed that after evaluation, it was found that the femur was segmented inconsistently, with both oversegmentation and undersegmentation present.The clinical/medical investigation concluded that, per complaint details, the femoral block was a poor fit; therefore the surgeon chose to remove a few osteophytes in order to try to get a better fit, but there was a significant anterior gap which required an additional +2mm distal recut.Reportedly, the anterior cut and rotation were adequate for the 5-in-1 cut and the procedure was resumed after a non-significant delay with the same device without patient harm.The visionaire surgical technique, does recommend use of back-up instrumentation, if the adaptive guide be determined unsuitable for its intended use.As of the date of this medical investigation, the requested clinical documentation has not been received.Based on the limited information provided, there were no definitive clinical factors found that would have contributed to the reported event.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure with the same device within a 0-30 minute surgical extension with a change of surgical technique and no patient injury was alleged.Based on this information, no further medical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the inspection drawing, part number, size, recut type, blade thickness and part configuration should be verified, it also has to be verified that the part should be free of burrs, damaged areas and sharp edges, besides dimensions should be measured with caliper to ensure print specifications.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be inconsistent femur segmentation, with both oversegmentation and undersegmentation present.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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