It was reported that on literature review clinical outcomes of the acufex trunav retrocutter drill for tunnel creation for acl reconstruction, after an acl reconstruction procedure, where a trunav drill was used to create the fitted bone tunnels, 4 patients required a revision surgery for a meniscal debridement and 1 other patient required a revision surgery for a meniscal repair.No further information is available.
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Smith and nephew has not received the device and/or adequate documentation to fully evaluate the root cause of the reported event.Therefore, the root cause of the reported dislocation and subsequent closed reduction and/or the patient outcome beyond that which was documented in the aged article cannot be confirmed nor concluded.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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