H3, h6: the device intended to be used in treatment has been returned for evaluation, all provided photos and information has been reviewed helping us establish a relationship between the event reported.Visual inspection confirmed silicon remained on the carrier, functional evaluation confirmed reduced adherence, root cause confirmed as raw material issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, complaint history review found other related events.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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