5.5 EXP VERSE FEN SCR 5.0X35

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: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE 5.5 EXP VERSE FEN SCR 5.0X35 (PART # 199723535, LOT # ATGCFM) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, THERE WERE NO VISUAL DEFECTS OBSERVED WITH THE DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED COMPLAINT DEVICE WAS NOT BE PERFORMED SINCE NO DEFECT WAS FOUND. FURTHERMORE, THE COMPLAINT-RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENTATION/ SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. INVESTIGATION CONCLUSION: THE COMPLAINT COULD NOT BE CONFIRMED AS NO DEFECTS WERE OBSERVED WITH THE DEVICE. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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: PART # 199723535, LOT # ATGCFM. THE DHR OF PRODUCT CODE: 199723535, LOT: ATGCFM WAS ELECTRONICALLY REVIEWED AND NO NON-CONFORMANCES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 19.05.2015, QTY: (B)(4). 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 SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 THAT THE INSERTER COULD NOT BE ENTERED CORRECTLY INTO THE CORRECTION KEY AND SLIPPED DURING THE FINAL TIGHTENING. THIS DAMAGED THE THREAD OF THE SCREW HEAD. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH REPLACEMENT SCREW AND SET SCREWS. CONCOMITANT DEVICES: UNKNOWN TORQUE HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 2) UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN)) THIS REPORT IS FOR ONE (1) 5.5 EXP VERSE FEN SCR 5.0X35. THIS IS REPORT 4 OF 14 FOR (B)(4).