UNK - GUIDE/COMPRESSION/K-WIRES

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INSERTION OF A TIBIAL NAIL, THE NAIL WAS ADVANCED OVER A GUIDE WIRE WITH AN OLIVE TIP. DURING ONE OF THE SURGICAL STEPS (POSSIBLY DURING INSERTION), THE DISTAL INLAY WAS LIKELY DAMAGED. IN ANY CASE, THE GUIDE WIRE COULD NOT BE REMOVED THROUGH THE NAIL BECAUSE IT BECAME CAUGHT IN THE INLAY. A NEW NAIL HAD TO BE OPENED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

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.