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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional manufacturer narrative: additional device product codes: hxx, hwe.Initial reporter occupation: reporter is a j&j employee.Part # 05.000.008.Synthese lot # 005522.Supplier lot # 005522.Release to warehouse date: 02 dec2013.Supplier: triangle manufacturing.No ncrs 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.Service and repair evaluation: the customer reported the hand piece for battery powered driver (product code: 05.000.008 and lot number: 005522) buttons are defective.The repair technician reported the device does not run in in all three modes, crack on the contact plate, and membrane vent broken.The cause of the issue is damaged component.The item will be repaired per the inspection sheet and will be returned to the customer upon completion of the service and repair process.Attached service record router complete.Finalized service record will be archived.The evaluation was confirmed.Service and repair evaluation: it was reported that the buttons of device 05.000.008, hand piece for battery powered driver are defective.The repair technician reported that device does not run in fast forward, forward and reverse conditions, contact plate was cracked, membrane vent was broken, patina on d34, barriers and d41, d50 was cracked, damaged membrane vent, rusted internal components, black and brown residue on barriers, loctite on d56, d56 was broken in d34.Warranty replaced was the reason for repair.The cause of the issue was damaged component.The item will be forwarded to customer quality.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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