MIS TI CFX FEN POLY 7X50

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. H11 ADDITIONAL NARRATIVE INITIAL REPORTER ADDRESS: (B)(6). 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

IT WAS REPORTED THAT THE HEAD OF THE SCREW WAS REMOVING FROM THE SPINDLE WHEN IT WAS BEING SCREWED. THE PHYSICIAN USED ANOTHER PRODUCT. THERE WAS NO CONSEQUENCE FOR THE PATIENT.

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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A 20-MINUTE DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED.

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. H11 ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED IMPLANT REVEALED THAT THE FLEX BALL OF THE MIS TI CFX FEN POLY 7X50 WAS BROKEN, AND ONLY ONE FRAGMENT WAS RETURNED FOR EXAMINATION. THIS CONDITION PREVENTS THE SHANK AND THE HEAD FROM BEING CONNECTED. ADDITIONALLY, FOREIGN MATERIAL WAS OBSERVED INSIDE THE SCREW, POSSIBLY ORGANIC MATERIAL RESULTING FROM THE SURGERY. THEREFORE, THE REPORTED CONDITION CAN BE CONFIRMED. A COMPLETE POTENTIAL CAUSE FOR THE OBSERVED CONDITION CANNOT BE FULLY ESTABLISHED WITH AVAILABLE INFORMATION. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. VIPER CORTICAL FIX FENESTRATED SCREW SYSTEM SURGICAL TECHNIQUE 103407662 REV. 1 WAS REVIEWED AND THE FOLLOWING RELEVANT STATEMENT WAS FOUND AT PAGE 5. ALIGN THE TABS OF THE ALIGNMENT SLEEVE WITH THE ROD SLOT IN THE SCREW HEAD, ENSURING THAT THE SOFT TISSUE DOES NOT IMPINGE ON THE CONNECTION OF THE ALIGNMENT SLEEVE TO THE SCREW HEAD. THREAD THE ASSEMBLED ALIGNMENT GUIDE INTO THE SCREW HEAD. THIS WILL ALIGN THE SCREW SHANK TO THE SCREW HEAD. CONFIRM THAT THE ALIGNMENT DEVICE IS FULLY SEATED BY CHECKING THAT IT IS FLUSH WITH THE TOP OF THE ALIGNMENT SLEEVE WHEN FULLY THREADED INTO THE SCREW HEAD. PRECAUTION: THE ALIGNMENT GUIDE MUST BE USED FOR EACH SCREW INTENDED FOR CEMENT AUGMENTATION. WITHOUT THE ALIGNMENT GUIDE, THERE IS A POTENTIAL RISK OF CANNULA BREAKAGE. USE OF THE ALIGNMENT GUIDE WILL PREVENT UNDUE STRESS FROM BEING APPLIED TO THE CANNULA. A DIMENSIONAL INSPECTION NOT UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL EVALUATION WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MIS TI CFX FEN POLY 7X50 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 186727750. LOT NUMBER: 400786. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 27 MAY 2024. MANUFACTURING SITE: JABIL LE LOCLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.