Aspen surgical received a report from the end user indicating that a bard-parker blade broke upon removing from the handle.No sample was available and no photographic evidence was available for evaluation.A manufacturing lot number was provided for review.End user indicated that the blade broke when trying to remove it from the handle.No injury was reported.Blade was not retained by the end user.A review of the device history record was completed and no non-conformance related to the reported issue were identified.Based on the information provided, 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 the end user by removing the blade from the handle could cause blade breakage.The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) 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.Incident was reviewed with production personnel.No further action is required.
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