Device was used for treatment, not diagnosis.Additional narrative: there was no reported patient involvement associated with the complained event.Event date: unknown.Device is an instrument and is not implanted/explanted.A service and repair evaluation was performed for the returned subject device.The customer reported the soft tissue retractor was missing a piece.The repair technician reported the blade was missing, and the locking nut was chipped and missing a piece.¿missing parts¿ is the reason for repair.The cause of the issue is unknown.The following parts were replaced: locking nut, blade.The item was repaired per the inspection sheet, passed synthes final inspection on apr 11, 2017 and will be returned to the customer upon completion of the service and repair process.The service and repair evaluation confirmed the complaint condition.A service history record review was performed for the subject device.The previous service event for part number 328.010 with lot number(s) 1770416 has been reviewed.No service history review can be performed as the item has not previously been sent in for service.There is no relevant information to the current complained issue.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: nov 26, 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 initially reported that a soft tissue retractor device was found to be missing a piece upon inspection after sterile processing.It is unknown when the component piece was lost.There was no reported patient or surgical involvement.This event was initially determined to be a non-reportable event.Upon return of the instrument to the synthes manufacturer, the repair technician reported the blade was missing, and the locking nut was chipped and missing a piece.The event was reevaluated and determined to be reportable.This report is 1 of 1 for (b)(4).
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