(b)(4).Type of investigation codes: analysis of production records - a review of the retained manufacturing/quality records confirmed that the device was manufactured to specifications.No previous complaints/issues have been logged for the remainder of the batch.Specific emphasis was directed toward the porosity results; which clearly indicate good results in the lower end of the test.Historical event analysis & trend analysis: a review of similar events for gelweave branded devices provided an occurrence (b)(4) (complaint v sales).No reports of leakage has been received for any of the remaining grafts from this batch.No negative trend was identified.Communication / interviews.- further information was requested from the site with regards to the circumstances of the event.Device not accessible for testing - device remains in situ and was not explanted.Investigation findings: no device problem found.Review of all retained manufacturing records (including porosity test records) confirm that the device was manufactured to specifications.Investigation conclusion: cause not established.Based on all available information provided by the site and that the actual device is not available, no determination of a root cause has been possible.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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