Reported issue - surgeon brought to attention that the leg holder had chipped and had an exposed sharp edge.
Product inspection - visual inspection confirmed leg holder is chipped.
Product history review ¿ a review of the product history records indicates that 20 devices were manufactured under catalog #210080 lot no 201843101633, and all were accepted into final stock on 02/03/2020.
There were no non-conformities identified during inspection.
Complaint history review ¿ a review of complaints related to p/n (b)(4), lot 201843101633 shows no additional complaint(s) related to the failure in this investigation.
Nc/capa history review - a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Conclusion ¿ the event was confirmed.
Per (b)(4), 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.
No additional investigation or specific actions are required.
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