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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TIBIA NAIL ADVANCED CASE THE PROXIMAL SCREW TARGETING WITH THE AIMING ARM FAILED. TO RESOLVE THE ISSUE THE CONSULTANT DECIDED TO GO FREE HAND WITH THE DRILL. THIS CAUSED A SLIGHT DELAY ON SURGICAL TIME. THIS HAPPENED USING THE NEW TNA INSERTION HANDLE. THE CONNECTING SCREW LOOKS LIKE THE OLD ONE, NOT THE REINFORCED ONE. THE PATELLAFEMORAL JOINT SPACE DIDN¿T SEEM TOO TIGHT. THE NAIL WAS NOT TOO OVERLY INSERTED.