5.5 EXP VERSE FEN SCR 6.0X45

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: D9: DEVICE RETURNED TO MANUFACTURER H3, H4, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE WAS INSUFFICIENT EVIDENCE TO CONFIRM THAT MIGRATION OCCURRED, AS NO X-RAYS WERE PROVIDED. THE DEVICE EXHIBITS NORMAL WEAR DAMAGE CONSISTENT WITH IMPLANTATION AND EXPLANTATION PROCEDURE, TABS WERE REMOVED AND NOT RETURNED WITHIN THE DEVICE. A FOREIGN UNKNOWN SUBSTANCE WAS ALSO OBSERVED, MOST LIKELY THE RESIDUE OF CEMENT FROM A SURGICAL PROCEDURE. A FUNCTIONAL EVALUATION WAS CONDUCTED, AND THE DEVICE WAS ASSEMBLED AND DISASSEMBLED WITHOUT ISSUES; THE SET SCREW REMAINED SECURELY IN PLACE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT DID NOT APPLY TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE 5.5 EXP VERSE FEN SCR 6.0X45 WOULD NOT CONTRIBUTE 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 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 REVIEW (DHR): A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PART: 199723645S LOT: 353009 IT WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES /MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE PRODUCT WAS RELEASED ON: 03-JAN-2023 MANUFACTURING SITE: JABIL LE LOCLE EXPIRY DATE:30-SEP-2027. CORRECTED DATA: D4: PRIMARY UDI NUMBER UPDATED. 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

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. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J EMPLOYEE. H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2023. ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED FOR THE EXTENSION (L3/4/5.) DURING SURGERY, THE SURGEON CONFIRMED THAT THE SCREW AND THE SET SCREW ON L3 RIGHT WERE DISENGAGED. THE SURGEON DID NOT NOTICE IT ON THE PREOPERATIVE X-RAY IMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO (B)(4) WHICH REPORTS INITIAL SURGERY TO THE SECOND SURGERY FOR THE EXTENSION. THIS PC REPORTS THE SCREW DISENGAGEMENT FOUND IN THE SECOND SURGERY. THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 6.0X45. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).