(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary :the complaint device was received at the service center and evaluated.The sales rep reported an issue of the device was overheated.Per operational and diagnostic, this complaint can be confirmed.During evaluation, it was found that the device was overheated due to a seized motor.Additionally, the cable was causing the device to display short errors, the keypad was not functioning due to corrosion, the button cover and valve handles heavily scratched.Performed repair as identified in the investigation to address the reported issue by replacing the motor, cable, keypad pcb, screws & button cover, and micro valve set.The unit passed all functional tests and is fully operational.Per repair analysis, the handpiece was found to be physically damaged.The seized motor is identified as the root cause of the reported problem of the device was overheated.Fluid ingress into the keypad might have caused corrosion of the keypad.User mishandling is the possible root cause for the observed scratches on the button cover and valve handles.With the given information, we cannot determine the root cause of the defective cable or damaged handpiece.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances were identified.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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