H3, h6: the device was not returned for evaluation but the reported event could be confirmed according to the engineering evaluation.The clinical/medical investigation concluded that, per complaint details, the visionaire¿ guides resulted in ¿extreme external rotation¿; therefore, the surgeon changed to convention instrumentation and ¿corrected that inter-op and sized up one size¿ on the femur and tibia.Reportedly, the surgery was performed with a change in the surgical technique without patient injury within a 0-30 minutes surgical extension.Further clinical documentation has not been provided as of the date of this medical assessment.The engineering evaluation confirmed an ¿over-segmentation of the posterior femur¿ and ¿downsizing the femur¿ as potential root causes for the stated failure mode.The visionaire¿ surgical technique does recommend use of back-up instrumentation should the adaptive guide be determined unsuitable for its intended use.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure within a 0-30 minute surgical extension with a change of surgical technique and ¿corrected that inter-op¿ with no patient injury alleged.Based on this information, no further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 with inspection drawing, part number, size, implant type, hand, recut type, saw blade thickness and part configuration should be verified, besides dimensions should be measured with caliper to ensure print specifications.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that the oversegmentation of the posterior femur would have affected the rotation of the femur.It was also determined that tibia implant was internally rotated instead of being externally rotated as stated in the complaint.It was also determined that the femur was downsized to match compatibility with the tibia size when the engineer should have upsized the tibia for compatibility with the femur.Based on this investigation, the need for corrective action is not indicated as the failure mode rate is within the anticipated acceptable risk limit in the risk management plan.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Possible causes could include a defect during manufacturing processes, including segmentation error and downsizing the dimension of the device.The contribution of the device to the reported event could be corroborated due to errors during manufacturing process, generating an extreme external rotation and a delay during surgery.Based on this investigation, the need for corrective action is not indicated.Should the device or 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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