H3, h6: the device, intended to be used in treatment, has not been returned for evaluation.The information provided has been reviewed and we cannot confirm a relationship between the device and the reported event.A review of the manufacturing records confirmed the device was released according to specification.A further review of the manufacturing process was also performed, and a root cause of inadequate standard operating procedure has been assigned.A complaint history review was performed for the product and event description, there have been further instances of this nature.Corrective action has been assigned regarding this event to reduce the probability of further reoccurrences.This investigation is now complete, smith + nephew will continue to monitor for any adverse trends relating to this product range.
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