CONFIDENCE HYDRAULIC PUMP

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE CONFIDENCE HYDRAULIC PUMP (PART # / LOT #) WAS RECEIVED AT US CQ ASSEMBLED WITH ALL COMPONENTS PRESENT. THERE WAS NO OBVIOUS DAMAGE TO NOTE. THE RECEIVED CONDITION HAD THE PISTON ALMOST FULLY ENGAGED WITH THE STERILE WATER. THE PUMP NUT WAS NOT FULLY THREADED THROUGH THE BODY. FUNCTIONAL TEST: FUNCTIONAL TESTING OF THE HYDRAULIC WAS PERFORMED. IN ITS RECEIVED STATE, THE PUMP NOT WAS NOT FULLY THREADED THROUGH THE BODY. THE DEVICE WAS HELD IN VARIOUS STATIC POSITIONS TO CHECK FOR LEAKS. NO LEAKAGE OCCURRED. THE HANDLE WAS THEN ROTATED TO TEST FOR ANY LOOSENESS OR JAMS WITH THE PISTON ASSEMBLY. THE HANDLE ROTATED SUCCESSFULLY ALL THE WAY TO ITS LOOSEST STATE. THE PUMP NUT WAS THEN ABLE TO BE LOOSENED BY FURTHER ROTATING THE HANDLE. THE DEVICE WAS DISASSEMBLED THEN RE-ASSEMBLED. THE PUMP NUT WAS ABLE TO FULLY THREAD ONTO THE BODY, AND ONCE AGAIN DID NOT LOOSEN UNLESS THE HANDLE WAS FURTHER ROTATED IN ITS MOST LOOSE POSITION. NO EVIDENCE OF FUNCTIONAL ISSUES COULD BE IDENTIFIED WITH THE DEVICE, ALL COMPONENTS FUNCTIONED AS INTENDED AND WERE IN GOOD SHAPE. AFTER VISUAL AND FUNCTIONAL INSPECTION, NO DEVICE DEFECTS COULD BE IDENTIFIED WITH THE RECEIVED PUMP. CONCLUSION: THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR THE RECEIVED CONFIDENCE HYDRAULIC PUMP AS NO DEFECT COULD BE IDENTIFIED AFTER VISUAL AND FUNCTIONAL INSPECTIONS. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING INVESTIGATION. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: THE DHR OF PRODUCT CODE 283906100, LOT 260336, WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON OCTOBER 30, 2019. QTY. (B)(4). THE DHR WAS ELECTRONICALLY REVIEWED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION 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.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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.

Additional Manufacturer Narrative

COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT AN UNKNOWN SURGERY TO STOP THE CEMENT FLOW THE PRESSURE IN THE HYDRAULIC PUMP IS REDUCED BY UNSCREWING THE HOLDER. WHILE UNSCREWING THE HOLDER THE INNER THREAD GOT JAMMED. THE INNER PISTON GOT LIFTED OUT WHICH RESULTED IN THE LIQUID TO FLOW OUT. THE INNER PISTON WAS PUT BACK IN PLACE AND COMPLETE THE CEMENT AUGMENTATION SUCCESSFULLY. THERE WERE NO FRAGMENTS CREATED. THE SURGERY WAS DELAYED TWO MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 2 OF 2 FOR (B)(4).