Integra completed its internal investigation 01/05/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: returned unit was received still assembled, however, excessive movement found in swivel base when index knob is locked.All related components including swivel base, round head screw and adjustment screw have been replaced to eliminate the excessive movement as identified.During testing, torque screw was found to not meet manufacturer¿s specifications and has been replaced free of charge.Device has been serviced, meets manufacturer¿s specifications and is now ready for clinical use.This device was manufactured on september 30, 2011 and a review of dhr's containing lot code 117 showed that the following lots passed the required inspection points without mrr's or variances service history: date of service: (b)(6) 2015.No new design or manufacturing trends have been identified.Conclusion: in summary, the end users experience could not be duplicated or verified.General maintenance was required of this returned device.
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