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Patient 1
(B)(4). VISUAL EXAMINATION OF THE HYDRAULIC PUMP REVEALED THAT THE PUMP'S TUBE HAS BROKEN INTO TWO PIECES, WITH THE HANDLE MECHANISM ATTACHED TO ONE OF THE MAIN PIECES. ALSO, THE HOSE CONNECTING THE HYDRAULIC CYLINDER AND THE RECTUS CONNECTOR IS SEPARATED. NO DIFFICULTIES ENGAGING AND DISENGAGING THE RECTUS CONNECTOR AND THE QUICK-CONNECT FEATURE OF THE CEMENT RESERVOIR CONNECTION WERE DETECTED. VISUAL OBSERVATIONS IDENTIFIED THAT THERE WAS HARDENED CEMENT INSIDE THE CONFIDENCE INJECTOR BODY. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. THE ROOT CAUSE OF THE PUMP BREAKING DURING USE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE IMPERFECTIONS CAUSE WHILE STAKING THE PUMP?S TUBE TO THE INSIDE OF THE BODY OF THE PUMP. FUNCTIONAL ANALYSIS OF THE HYDRAULIC PUMP REVEALED NO DIFFICULTIES ENGAGING AND DISENGAGING THE RECTUS CONNECTOR AND THE QUICK-CONNECT FEATURE OF THE CEMENT RESERVOIR CONNECTION. THEREFORE, THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.