Boot chipped and now has sharp edge.Product inspection: the product was not evaluated as the product was unavailable for inspection capa: 2127499 has been raised for the same.Product history review: review of the product history records indicate that under lot no: 201843071007: 1.(b)(4) devices were manufactured and accepted into final stock on 07/18/2019.No non-conformances were identified during inspection.2.(b)(4) devices were manufactured and accepted into final stock on 09/10/2019.No non-conformances were identified during inspection.3.(b)(4) devices were manufactured and accepted into final stock on 10/30/2019.No non-conformances were identified during inspection.4.(b)(4) devices were manufactured and accepted into final stock on 11/20/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 210080, lot number: 201843071007, shows 01 additional complaints related to the failure in this investigation.Conclusion: per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The failure mode cannot be confirmed as the product is unavailable for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|