The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.The clinical medical investigation concluded that per the complaint details, we currently are unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.After three requests no relevant clinical information, operative reports, or radiograph were provided.Based on the information provided, due to a gap between the insert and the baseplate, the surgeon used a smith and nephew back up device to complete the procedure.Since there was no injury to patient or significant delay reported, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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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