H3, h6: the device was not used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a root cause.A manufacturing process review was carried out.There are strict inspections during the manufacturing process to ensure that products that do not meet specifications are rejected.Probable causes may include human inspection failure during the packaging process.¿the batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.A review of complaint history did not reveal similar events for the listed batch and part number.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Internal complaint reference number: (b)(4).
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