There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 03.113.025, lot # 3665631: manufacturing site:(b)(4), manufacturing date: 28.Jan.2011: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service history review was performed for part # 03.113.025, lot # 3665631: no service history review can be performed as part number 03.113.025 with lot number(s) 3665631 is a lot/batch controlled item.The manufacture date of this item is 1-feb-2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.The device has been 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.
|
A service and repair evaluation was performed on subject device.The customer reported the insertion screw was missing.The repair technician reported the screw was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: m3.5 screw.The item was repaired per the inspection sheet, passed synthes final inspection on 1-jun-2017 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.
|