Aspen surgical received a report from the distributor indicating that a bard-parker blade broke off in a patient during a procedure.In this report, it was noted that no sample and no lot number was available for evaluation.During a shoulder arthroscopy procedure, the upper 3rd portion of a #11 bard-parker carbon rib-back blade broke off and became embedded in the tissue.The surgeon retrieved the broken piece from the tissue without incident.The patient tolerated well and follow up care was not required.Due to no sample and no lot number being provided, an evaluation of the dhr records could not be performed.Packing process has established controls to mitigate broken blade condition, including a blade sensor that inspect 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.Based on this information, no further action is required.
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