No patient involvement was reported.Date of event is unknown.Implant and explant date: device is an instrument and is not implanted / explanted.Service history review was attempted for part #: 03.501.080, lot #: 8652176.No service history review can be performed as part number 03.501.080 with lot number 8652176 is a lot/batch controlled item.The manufacture date of this item is oct 16, 2013.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part # 03.501.080, lot # 8652176.Manufacturing location: (b)(4), manufacturing date: oct 10, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service and repair evaluation was completed.The customer reported the device was in need of repair.The repair technician reported the device was sticky, the left guide was bent, and the nut and screws were loose.Bent is the reason for repair.The cause of the issue is unknown.The following parts were replaced: gen 2 handle screws (13).The item was repaired per the inspection sheet, passed synthes final inspection on nov 01, 2016 and will be returned to the customer upon completion of the service and repair process.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.
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