This is the first of two reports (same product id, same serial number, similar problem, different incidents).This report is in regards to the (b)(6) 2015 incident.The trunnion locking wheels seized up and the user was unable to unlock and rotate the loaner device.On (b)(6) 2015, the integra sales representative was able to free up the device and got approval from the operating room manager at the user facility to leave the device on site as a loaner.It was resterilized and put into service.The same occurrence happened again during a deep brain stimulation (dbs) surgery on (b)(6) 2015.There was no patient injury.Surgery delay was reported (exact time not provided).Additional information has been requested.
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Linked to mfg report number: 1222895-2015-00044.Integra has completed their internal investigation on (b)(4) 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: trunnion set screw was pushed in and made contact with spacer.Additionally, residue was found inside trunnion.Device history record reviewed for this product id lot # p1013 manufactured on 06aug2010 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.A two year review of complaints history shows that 17 complaints were received including this case.Conclusion: the set screws were forced to go beyond their settings.Residue is likely due to oil or cleaning agent used in cleaning and may have contributed to the sticking.Capa has been initiated to address this issue.
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