EXPEDIUM

Description of Event or Problem

IT WAS REPORTED THAT THIS WAS AN ME-PLIF (L3) FOR TRAUMA ON (B)(6) 2026. AFTER THE VERSE FS SCREW INSERTION, THE ALIGNMENT DEVICE WAS INSTALLED TO INJECT CEMENT AND THE OPEN CANULA IN QUESTION WAS ATTEMPTED TO INSTALL, IT COULD NOT GO IN STRAIGHT, DIRECTION OF THE ALIGNMENT DEVICE WAS ARRANGED AND ATTEMPTED TO INSTALL, THE TIP OF THE CANULA BROKE. THE BREAKAGE PART REMAINED IN INSIDE A HOLLOW SCREW SHAFT, BUT THE SURGEON FINALLY MANAGED TO REMOVE THE FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING A NEW ONE. ON POSTOPERATIVE X-RAY, THE REMAINING BROKEN PART WAS NOT FOUND.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.