Additional narrative: event date: unknown.Additional product code: gxl.Device is an instrument and is not implanted/explanted.Service history review: lot 0050341: a service history of the past three years has been reviewed.The item was previously returned for service on (b)(4) 2014 due to motor failure.The customer called in a service request for this item on (b)(4) 2015 and reported the device is in need of service, inoperable.The previous service condition of motor failure is relevant to the current complained issue of the device is in need of service, inoperable.The service history evaluation is confirmed.A service and repair evaluation was completed: the customer reported the device required service.The repair technician reported the motor was making a buzzing sound, and the reverse speed did not work.Motor failure is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.This item was repaired, passed synthes final inspection and returned to the customer.The evaluation was confirmed.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.
|