Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received at the service center and evaluated.The defect reported by the customer has been verified and repaired.The following repair activities were performed: "micro": preventive replacement of o-rings performed; motor does not turn: motor replaced; motor corroded - motor replaced; insulation resistance out of tolerance: motor cable replaced; resistance value out of specs: handcontrol set replaced; contacts of the keypad corroded: handcontrol set replaced; defective drill mounting mechanism has been replaced; defective o-rings replaced; functional test performed; electrical safety test according to completed.As per the input check report the buttons not functioning,the cable's insulation resistance is out of range, the motor is corroded and doesn't run are the possible root causes of the reported failure.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.(b)(4).
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