It was reported that during procedure when the tibial intramedullary nail was finally put on the nail cap, there was a problem with the thread of the nail cap, which could not be screwed in.Surgery was completed with an s+n backup device.No information about injuries or surgical delays were reported.
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The device, used in treatment, was returned for evaluation.A visual inspection confirms the stated failure.The threads are damaged on the nail cap.The device was manufactured in 2019.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 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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