VIPER MONO SCREW 5X50MM TI

Description of Event or Problem

DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PSF (L2) FOR BURST FRACTURE OF L1 ON (B)(6) 2023. PPS WAS DONE AT TH10-L2, AND THE SCREWS IN QUESTION WERE USED ON BOTH SIDES OF L2. XTAB CFS WAS INSERTED IN TH10, MONO SCREWS WERE INSERTED IN TH12, WITH TH10 AND TH12 IN FINAL TIGHTENING, A V3D DISTRACTOR WAS USED TO STRETCH BETWEEN TH12/L2. AFTER DISTRACTION WAS DONE, THE SURGEON TIGHTENED THE SCREWS FURTHER WITH A SCREWDRIVER AND TRIED THE FINAL TIGHTENING OF SCREWS, THE SCREWS SEEMED TO GET STRIPPED. THE SCREWS WERE REMOVED AND THE THREADS ON THE SCREWS WERE FOUND TO BE DAMAGED. THE SURGEON USED OTHER SET SCREWS AND TRIED TO DO THE FINAL TIGHTENING, BUT THE SITUATION DID NOT CHANGE. THEREFORE, THE SALES REP RECOMMENDED THE REMOVAL OF THE SCREWS. THE SURGEON REMOVED THE SCREWS AT THE SURGEON¿S DISCRETION, INSERTED OTHER SCREWS, DID THE DISTRACTION CAREFULLY, AND DID THE FINAL TIGHTENING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 90 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VIPER MONO SCREW 5X50MM TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

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. ADDITIONAL NARRATIVE: KWQ, MNH, KWP, MNI, NKB. STATE: MIYAGI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (510K): UNKNOWN. DEVICE HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VIPER MONO SCREW 5X50MM TI WAS CONDUCTED IDENTIFYING THAT LOT NUMBER RL255357 WAS RELEASED IN ONE BATCH. SUPPLIER: RTI REMMELE MEDICAL, INC. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED (B)(6) 2017 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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.