H3, h6: the device was not returned for evaluation, the reported event cannot be confirmed.A documentation review was performed.Historical review has revealed previous cases of a similar nature, there are no open nor closed escalation actions within the scope of this event type.Risk management files adequately mitigate the event, no updates are required.Without details of the device serial number a review of the manufacturing records could not be performed.The instruction for use and risk files delineate the reported event, advising the user to discontinue using the device if defects are observed.Without details of the device serial number confirmation that the manufacturing records details that the device met the final product specifications prior to release cannot be confirmed.No corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.
|