Aspen surgical received a report from the distributor indicating that a blade broke at the handle slot.No adverse effect to the patient was noted.Photographic evidence was available for evaluation.A manufacturing lot number was also provided for review.Customer reported that the blade broke at the attachment location to the handle.Patient was not affected.A review of the device history record was completed.No non-conformance's relating to the reported issue were identified.A review of the photographic evidence confirmed the reported issue of the broken blade.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user could also cause blade to break.The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Based on this information, no further action is required.Device not returned.
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