Integra has completed their internal investigation on (b)(6) 2015.The investigation included: evaluation of actual device.Review of device history records.Review of complaints history.Results: device history record reviewed for this product id serial # (b)(4) manufactured on march 12, 2015 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No service history on file for this device.A two year lookback in trackwise for this reported failure and or related to " torque knob washer and nut came loose" for this product id shows that 5 complaints were received including this case.No new design or manufacturing trends have been identified.Conclusion: the complaint device noted in this report (pr130003) likely failed as a result of being subjected to a traumatic event, significant enough to not only cause the torque screw to disassemble, but also cause the piston to bend approximately.020¿ (.040¿ tir) {causes unknown at this time}.
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