5.5 EXP VERSE FEN SCR 6.0X45

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). 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. 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 THE PATIENT UNDERWENT AN L1/2 TLIF ON (B)(6) 2025; THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, A CT SCAN SHOWED BILATERAL BREAKAGE OF THE L1 SCREW; THE SCREW BROKE NEAR THE LATERAL HOLE OF THE SCREW.

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: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H6: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE CT SCAN PHOTOGRAPHS ATTACHED WERE REVIEWED, HOWEVER THE IMAGE QUALITY IS POOR AND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED. THEREFORE, WHIT THE EVIDENCE PROVIDED IT'S NOT POSSIBLE TO CONFIRM THE ALLEGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS ATTACHED ARE INSUFFICIENT TO DRAW A CONCLUSION ABOUT THE REPORTED EVENT. 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 COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES 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 LOT: A DHR EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 199723645S LOT NUMBER: 374740 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 28-JUL-2023 MANUFACTURING SITE: JABIL LE LOCLE IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.