Expiration date : 06/08/27 (08-june-2027).The reason for this complaint was reported as mislabeling or incorrect marking.The healthcare professional indicated this event occurred during surgery, away from the patient.There was no risk or adverse event reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the device history records (dhr) wo#a13458227 130-03-738 and wo#a13469997 509-01-032 indicates that both lots were for 17 pieces.Both work orders were processed by the same operator through flow bench verification and tray kit assembly.Both work orders were processed by the same operator through seal - tray assembly.The labels on the bottom of the tray, petg, and outer packaging all match.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.A review of the complaint databased identified for the same lots and for the same alleged issue.This complaint is also linked to hhe-2022-00008.The root cause of this complaint is likely due to the parts were swapped between the part verification/tray kitting and the tray seal operation.Rma examination: the reported device was returned to djo surgical for evaluation.There was a domed tri-peg patella within the humeral socket insert packaging.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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