Symmetry surgical's supplier stated that the affected product was part of a production batch of (b)(4).Their production documentation quotes that all manufacturing steps for the whole batch were carried out according to the requirements of their production router.Final inspection after production was conducted according to aql 2.5; so 13 pcs.Were inspected.The part returned by the customer was not subject to this inspection and was sent out with a sharp working end.It is clear that the product missed the edge rounding process at the suppliers manufacturing facility.The supplier has completed training to ensure that this process gap is eliminated.Supplier will also be completing a 100% inspection of the next three production batches of part#50-8011 to ensure that devices do not get through with sharp edges.Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, another follow up report will be submitted.
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