Procode: gxl, hxx.Reporter is a j&j sales representative.A product investigation was conducted.Service and repair evaluation: the repair technician reported the bearings were grinding, there was debris in the housing.The device did not run in fast forward, forward, or reverse.Damaged component is the reason for repair.The cause of the issue is damaged component.The following parts were replaced: circuit board, motor, membrane switch/flex circuit, and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on 12-apr-2021 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part # 05.000.008, synthes lot # 005864, previous synthes lot # 004470, supplier lot # 004470, release to warehouse date: 09 dec 2011, supplier: triangle manufacturing, no ncr"s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
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It was reported on an unknown date, during routine inspection it was discovered that the hand piece for battery powered driver does not work consistently, different batteries tried to confirm but it stops while button pushed.There was no patient involvement reported.During manufacturer's investigation of the returned device it was observed that the bearings were grinding and there was debris in the housing.The device did not run in fast forward, forward, or reverse.This device condition was evaluated and determined to be reportable on april 28, 2021.This report is for one (1) hand piece for battery powered driver.This is report 1 of 1 for complaint (b)(4).
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