The most probable root cause is the stamping or grinding process; however, the customer was unable to provide a lot date or return the sample for evaluation.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.A 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process.Each associate performing 100% inspection process is certified and re-certified on an annual basis on blade defect criteria¿s.Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/15.New capa (b)(4) was initiated for the broken blade defect.Device not received from customer.
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