Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional device product codes: hxx, hwe reporter is a j&j employee.Part # 05.000.008.Synthes lot # 007754.Supplier lot #: 007754.Release to warehouse date: 17 feb 2020.Supplier: (b)(4).No ncr's 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.Service and repair evaluation: the customer reported that for the device 05.000.008, handle battery powered driver all speeds barely move.The repair technician reported contact pins were damaged, membrane vent and wires were discolored, barrier was burnt and brown residue were found on barriers, circuit board was damaged, motor was rusted, the device ran low in fast forward, run intermittently in reverse conditions.Preventive maintenance is the reason for repair.The cause of the issue is unknown.The following parts were replaced: circuit board, shrink tubing, motor/gearhead, cam screw, membrane switch/flex circuit and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on 23-nov-2022 and will be returned to the customer upon completion of the service and repair process.Service record router completed.Finalized service record will be archived.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.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 that on (b)(6) 2022, during a weekly audit, it was found that on the hand piece for battery powered driver, all speeds barely move.There was no patient involvement.No further information is available.This report involves one hand piece for battery powered driver.This is report 1 of 1 for (b)(4).
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