Aspen surgical received a report indicating that a blade broke during a procedure.No injury or death was reported.Item was in use at the end user.No sample, photographic evidence, or lot number was available for evaluation.Information from the end user noted that the blade broke while in use and that there was no harm to the patient and no delay to the procedure.Due to no lot number available, the device history record could not be reviewed.However, 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 during surgery process could also cause blade condition.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 additional actions required.
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