Additional information provided in d.9., h.3., h.6.And h.10.Three opened trocar assemblies, in a small parts tray (smpt), in a bag, with no lot info were received.Three samples were visually inspected and found to be nonconforming.Sample # 1 and #2 - trocar blade was observed to have a damage cutting edge and bent tip.Sample # 3 - trocar blade was observed to have a damage cutting edge.Penetration testing could not be performed due to the damage of the samples.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.The exact root cause could not be determined from the investigation performed.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The damage seen on the returned complaint samples could have contributed to the customers reported issue of trocar could not cut.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformances, such as damaged tips and damaged cutting edges, are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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