UNK - GUIDES/SLEEVES/AIMING: AIMING ARM

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: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. E1. INITIAL REPORTER ADDRESS LINE 1: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT DURING A TIBIAL NAILING PROCEDURE, THE DRILL BIT CONTACTED THE NAIL ON THE PROXIMAL SIDE OF THE HOLE WHILE DRILLING THE S1 SCREW, RESULTING IN AT LEAST ONE DRILL BIT BEING OBSERVED AS NOT STRAIGHT AND EXHIBITING WOBBLING WHEN USED. THE PROCEDURE WAS COMPLETED BY LOCKING THE SCREWS USING THE FREEHAND TECHNIQUE. THE TIBIAL NAIL WAS IMPLANTED AND IS NOT AVAILABLE FOR RETURN. THE EVENT LED TO A SLIGHT DELAY IN SURGERY, BUT THERE WAS NO REQUIREMENT FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION, NOR WAS EXTENDED HOSPITALIZATION NECESSARY.