2.0MM ANGLED AWL

Description of Event or Problem

IT WAS REPORTED ON (b)(6) 2026, THAT WHILE USING THE ANGLED AWL TO PLACE A PILOT HOLE FOR SCREWS THE TIP BROKE OFF INTO THE IMPLANT AND PATIENT'S CERVICAL BODY. THE DEVICE WAS ALSO CROSS THREADED. THE SURGEON WAS ABLE TO GRAB THE END AND RETRIEVE ALL OF THE INSTRUMENT. NOTHING WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDED 5 MINUTES TO THE PROCEDURE.

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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.