Aspen surgical received a report from the end user indicating that a bard-parker blade broke prior to applying during a procedure.No sample was available and no photographic evidence was available for evaluation.A manufacturing lot number was not provided for review.End user indicated that the blade broke prior to the surgeon putting stress on the blade.Blade was not retained as noted by the end user.Due to no lot number available, no review of the device history record could be completed.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.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.Incident was reviewed with production personnel.No further action is required.Device not available.
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