The most probable root cause could have been during the stamping or grinding process, however, no samples were provided for evaluation.A 100% visual inspection by certified personnel is performed prior the assembly and packaging operation.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.¿ 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 10/26/2015.¿ capa (b)(4) was also initiated to continue in the monitoring and improvement of current control.Device not available.
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