Additional information provided in d.10., h.3., h.6., and h.10.One opened 25 gauge trocar assembly without a cap in a small part tray (smpt) within a bag was received for the report of dull blade, trocar could not be set to sclera.The trocar cannula/hub assembly is not seated correctly on the blade/handle assembly.The sample was visually inspected and was found to be nonconforming with a damaged tip and a damaged cutting edge.Penetration testing could not be performed due to the damage of the sample.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 sample 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 sample could have contributed to the customers reported issue of dull blade.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 nonconformance, such as the damage tip and damaged cutting edge are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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