WATSON EXTRACTION SYSTEM

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT THE STEM EXTRACTION VICE BECAME STUCK/COLD WELDED TO THE STEM TRUNNION DURING HIP SURGERY. WHILE REMOVING THE EXTRACTOR, THE TENSION BOLT SNAPPED JUST BELOW THE THREADS. NO PIECES WERE MISSING OR LOST. ALL PIECES WERE RETRIEVED FROM THE FIELD. THE SURGERY WAS DELAYED APPROXIMATELY FIVE MINUTES TO REMOVE THE EXTRACTOR BEFORE CONTINUING THE REMOVAL PROCESS. THE REMOVED STEM WAS A COMPETITOR¿S PRODUCT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.