The associated reflection liner was not returned for evaluation.Therefore visual inspection could not be performed.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.After repeated requests, smith and nephew has been unable to obtain device details.Thus, a review of the manufacturing records could not be performed.Complaint history review could not be performed with any accuracy due to lack of batch information.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.If the product associated with this event is returned at a future date, the evaluation will be reopened for investigation.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.
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