5.5 EXP VERSE FEN SCR 6.0X45

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BELGIUM. IT WAS NOTED THAT THERE IS NO CURRENT PLAN FOR ANOTHER PROCEDURE TO REMOVE THE REMAINING FRAGMENTS FROM 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. H3, H4, H6: PART 199723645, LOT 235783: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: MARCH 21, 2019. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE IT WAS OBSERVED THAT THE SHAFT OF THE SCREW WAS BROKEN. SIGNS OF USAGE WERE OBSERVED ON THE DEVICE, WHICH COULD HAVE BEEN DUE TO THE IMPLANTATION AND EXPLANTATION PROCESS. NO OTHER ISSUES WERE IDENTIFIED. THE REPORTED CONDITION OF EMBEDDED DEVICE COULD NOT BE CONFIRMED AS NO X-RAYS WERE PROVIDED. DIMENSIONAL INSPECTION SHOWED THE RELEVANT DIMENSIONS WERE CONFORMING. THE CURRENT AND MANUFACTURED TO DRAWINGS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THIS COMPLAINT COULD BE CONFIRMED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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. 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

REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, DURING THE REVISION THEY NOTICED THAT THE SCREW WAS BROKEN AROUND 1,5CM ABOVE THE TIP AND THE FRAGMENTS WERE STILL LEFT IN THE PATIENT. INITIAL SURGERY WAS DONE IN 2018. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).