Device is an instrument and is not implanted / explanted.Service history review was attempted for part#: 03.501.080, lot#: 9761211.No service history review can be performed as part number: 03.501.080 with lot number: 9761211 is a lot/batch controlled item.The release to warehouse date of this item is mar 31, 2016.The service history review is unconfirmed.Device history records review was completed for part#: 03.501.080, lot#: 9761211.Manufacturing location: (b)(4), manufacturing date: mar 24, 2016.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.The device was received and the product evaluation is in progress.No conclusion can be drawn.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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Device was used for treatment, not diagnosis a service and repair evaluation was performed.The customer reported the item was not cutting.The repair technician reported the zipfix was binding.Lube/oil/clean is the reason for repair.The cause of the issue is unknown.No parts were replaced.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2016 and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.Service history review was attempted for part# 03.501.080, lot# 9761211.No service history review can be performed as part number 03.501.080 with lot number 9761211 is a lot/batch controlled item.The release to warehouse date of this item is (b)(6) 2016.The service history review is unconfirmed.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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