Batch review performed on 22 january 2019.Lot 153879 : (b)(6) items manufactured and released on 29 february 2016.Expiration date: 2021-01-26.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any similar reported event.Investigation performed by coating supplier: the particle loss is associated with a final finishing not properly performed; but also, since the tigrowh-v is a very porous and wrinkled coating, it can not be completely avoided.Moreover, packaging and the continuous movement of the piece inside the blister during shipment, accentuates this phenomenon.Based on the fact that the implant was anyway implanted, probably the surgeon has considered the episode as non-critical.The manufacturer has improved the production controls such as check of the boxes before shipment.Preliminary investigation performed by r&d product manager: the image was analyzed.From the received image it is not possible to determine the root cause of the event; the event could be related to different phenomena, like the typology of the coating, which is highly wrinkled, the packaging and eventual movements of the piece inside the blister during the shipment.
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