Aspen surgical received a letter from the fda (reference number mw5077361) indicating that a bard-parker blade broke while in use during a procedure.The incident occurred at the user facility.No sample and no photographic evidence was available for evaluation.A manufacturing lot number was also unavailable for review.Bard-parker size 11 scalpel tip broke off in the patient's neck during an emergent cricothyrotomy.The broken blade tip was successfully retrieved from the patient's neck in the or.The blade was not tagged or saved after the event.No additional treatment was required.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.Device not available.
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