BLADE/SCREW GUIDE SLEEVE

Description of Event or Problem

IT WAS REPORTED THAT DURING TFNA SURGERY, THE SURGEON SUCCESSFULLY IMPLANTED THE TFNA NAIL AND THE HELICAL BLADE. UPON ATTEMPTING TO RELEASE AND REMOVE THE BUTTRESS COMPRESSION NUT AND BLADE/SCREW GUIDE SLEEVE FROM THE AIMING ARM LOCKING DEVICE, THE NUT AND SLEEVE WOULD NOT COME OFF. THE SURGEON EVENTUALLY REMOVED THE AIMING ARM, AND THEN HAD TO FORCEFULLY REMOVE THE COMPLAINED ITEMS USING A MALLET ON THE BACK TABLE. THEN THE SURGEON WAS ABLE TO SUCCESSFULLY REATTACH THE AIMING ARM AND THEN FINISH THE SURGERY SUCCESSFULLY ACCORDING TO THE CORRECT TECHNIQUE. THE BUTTRESS COMPRESSION NUT AND BLADE/SCREW GUIDE SLEEVE SUSTAINED SIGNIFICANT DAMAGE IN THE REMOVAL PROCESS. UPON INSPECTION BY THE STAFF FOLLOWING THE PROCEDURE, THE METAL ON THE INNER CIRCULAR LIP OF THE BUTTRESS/COMPRESSION NUT WAS BENT AND GOUGED, AND THE ¿TOOTH¿ OF THE BLADE/SCREW GUIDE SLEEVE WAS BENT INWARDS. BOTH COMPLAINED ITEMS WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

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