Aspen surgical received a report from the distributor indicating that bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.No sample was available for evaluation.Photographic evidence and manufacturing lot number was provided for review.During a procedure, the blades broke upon initial incision into the deep layer tissue at the beginning of the case; two blades broke in half.Additional new blades were obtained.All pieces were immediately retrieved from the patient.No additional treatment was required for the patient.A review of the device history record indicated no non-conformance's related to the reported issue.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 (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.Based on this information, no further action is required.
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