The reason for this complaint was reported as lot number on the package differs from the lot number on the product and stickers.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse outcome was reported by the surgeon.The surgery completed as intended.The device was inspected prior to use and was determined to be unacceptable.The device was returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of manufacturing records indicate that universal tibia baseplate size 6 (352-02-106) was manufactured december 16, 2021 on work order a12799759 and universal tibia baseplate size 6 minus (352-04-106) was manufactured march 18, 2019 on work order (b)(4).Work order (b)(4) had a ncmr generated indicating that one (1) piece would be split off for rework.However, the work order indicates that the parts were reworked on the original work order and then continued through the manufacturing process.A review of the label printing history does not indicate additional labels were printed later than when the work order was generated.The rep who initiated the complaint reviewed x-rays from a surgery performed in (b)(6) 2022 using 352-04-106, 6 minus baseplate, and verified the correct implant was in the patient.Based on the transactions, all 19 parts of 352-04-106, 6 minus baseplate, were shipped from djo surgical at the latest date of 11/21/19.A review of material transactions does not indicate an overlap in timeframe of when the product was in inventory.Complaint database review showed no previous complaints for the reported lot numbers that allege this same issue.The root cause of this complaint is unknown.It is possible that the representative may have swapped the outer packaging in the field due to the manufacturing dates occurring at different times.Containment is to take place in accordance to hhe-2022-00003.Rma examination: the rma was returned to djo surgical for evaluation.The packaging was not provided to verify the discrepancy, however, the device provided matches the images the sales representative had provided.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
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