One opened knife sample was received by manufacturing correctly seated in a tray with a foam blade protector.The returned sample was visually inspected and was found to be nonconforming with a damaged tip.Penetration and sharpness 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 exact root cause could not be determined from the investigation performed.The damage seen during evaluation could be seen by the naked eye as a burr on the end of the blade, as was reported.The damage to the returned sample 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 sample 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 exhibited on the returned opened sample, 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).
|