Investigation completed (b)(6) 2017.(b)(4).The device history record for this unit shows that this part was manufactured on (b)(6) 2016.A total of 40 were produced of this work order number and lot number.No abnormalities related to reported incident found nor were there any variances, mrr¿s or reworks associated with this work order number and lot number.No service history is on file for this device.Conclusion: in summary, the device in question was not received for evaluation after several documented attempts.Therefore, the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.
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Investigation completed 07/26/2017.Work order# 139300/ lot# 161/ serial# (b)(4).The device history record for this unit shows that this part was manufactured on 03/23/2016.No abnormalities related to reported incident were found, nor were there any variances, mrr¿s or reworks associated with this work order number and lot number.No service history is on file for this device.The customer removed the helicoil and returned the actual component (skull clamp helicoils coming off during pressure testing) that were removed from skull clamps repaired or in question.This customer sent in 21- gs127¿s (helicoils) that were removed from skull clamps repaired or in question.Due to how these helicoils were removed the heli coil threads were damaged thus we are unable to perform a dimensional inspection.We are also unable to trace these parts back to the device that it was removed from as these 21 pieces were received in one bulk bag with no supporting information.Root cause is undetermined at this time.
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