Product complaint #: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the button got a problem.Per service reports, this complaint can be confirmed.During evaluation, following defects/failures were noticed.Missing o-ring, the keypad was not responding properly, the values of the keypad were out of range, the motor was corroded and run not constantly, the protective earth resistance of the motor cable was out of range.The motor, motor cable, hand control set, o-ring were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Fluid ingress into the device and contact with the motor is responsible for the rusty motor.Corroded motor has a tendency to stick and not turn constantly.User mishandling most probably during cleaning process might have caused in missing o-ring.The drifting values would have caused the keypad not to respond properly, therefore is the root cause of the reported button problem.With the available information, we cannot determine the root cause of the other identified failures.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 06/25/2018 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.However, depuy synthes 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.Udi: (b)(4).
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