Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the pressure issue was found.Per service reports, this complaint can be confirmed.It was found during evaluation that the pressure were out of range.The y tube assembly were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The defective y tube assembly might be the most probable root cause for the pressure out of range.However, given the information provided, we cannot discern a definitive root cause for the same.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 10/30/2020 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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