Three opened trocar blade/handle assemblies were received in a small parts tray for the report of metal tip of trocar blade was broken during insertion.The trocar blade/handle assemblies were returned with not tip protectors.The samples were visually inspected and were found to be nonconforming with damaged tips and damaged cutting edges.A lot number was identified, however is not a valid lot number therefore, lot history and complaint history reviews were not conducted.The photo attached to the parent complaint was reviewed by the manufacturing site.The photo is of three trocar blade/handle assemblies with no tip protectors in a small parts tray.Only one of the trocar assemblies had a trocar hub/cannula assembly.The reported issue of trocar damaged blade can not be confirmed.The exact root cause could not be determined from the investigation performed.The returned samples are visually non-conforming with damaged tips and damaged cutting edges; therefore, a metal tip of the trocar blade was broken during insertion was confirmed; however, how and when the tip of the knives became damaged could not be determined.The exact root cause for the damaged trocar knife samples are unknown, therefore specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformance, such as the damaged tips and damaged cutting edges exhibited on the returned opened samples are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
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