Initial reporter is a synthes sales representative.Part 03.010.072, lot 3788247/1597033: manufacturing site: (b)(4).Release to warehouse date: july 22, 2011/november 29, 2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.A product investigation was completed: upon visual inspection, it was observed that the distal tip of the hook was bent and the slider assembly was missing the compression sleeve and the ball components.There were scratches and nicks on the device but have no impact on the device functionality.No other issues were identified with the returned device.A functional test was not performed as there was conclusive evidence that the returned device was missing components.No dimensional inspection can be performed due to post-manufacturing damage and missing components.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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, the depth gauge for locking screws to 100mm for nails would not slide.It is unknown if there was a surgical delay.It is unknown if procedure was successfully completed.There is no patient consequence.During the investigation by the manufacturer, it was noted the distal tip of the hook was bent and the slider assembly was missing the compression sleeve and the ball components.This report is for a depth gauge.This is report 1 of 1 for (b)(4).
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