The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical (b)(4): ¿ 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.¿ capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/15.¿ capa (b)(4) was also initiated to continue in the monitoring and improvement of current control.¿ awareness of the complaint received will be discussed with affected manufacturing personnel on 07/24/17.Device not returned for evaluation.
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