The repair technician reported the tip of the depth gauge is missing.Missing parts is the reason for repair.The cause of the issue is missing parts.The following parts were replaced: tip of depth gauge.The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2020 and will be returned to the customer upon completion of the service and repair process.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 history lot: part #: 319.090, lot #: 2263678 (us lot 5554772), manufacturing site: (b)(4), release to warehouse date: 12.Apr.2007.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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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It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the depth gauge was missing a piece.There was no known patient or hospital involvement.This report is for one (1) depth gauge for small screws.This is report 1 of 1 for (b)(4).
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