Two opened knife samples without tip protection were received in blister packages for the report of being burred and bent on the end of the blades.The returned samples were visually inspected and were found to be nonconforming with a damaged tip and a damaged cutting edge.A burr was not confirmed on either of the returned samples.Penetration testing could not be performed due to the damaged condition of the sample.A review of the device history record related to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates that there are no additional complaints associated with the lot for the reported issue.The returned samples were found to be nonconforming however a burr as described in the complaint was not confirmed.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 blade tray when the product is improperly removed or inserted after use, from improper handling or from contact with another instrument during surgery or set-up.The exact root cause for the damaged knife samples is unknown therefore, specific action with regards to this complaint cannot be taken.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Any nonconformance, such as the damaged tip and damaged cutting edge exhibited on the returned opened samples, is removed from the lot and scrapped.Functional penetration testing is performed and monitored during the finishing process to ensure the sharpness of the product.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.(b)(4).
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