ACTIS

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 DURING A TOTAL HIP REPLACEMENT SURGERY WHILE TRYING TO REMOVE THE BROACH FROM THE FEMORAL CANAL, THE MALE END WHERE THE BROACH HANDLE ATTACHES BROKE OFF IN THE BROACH ATTACHMENT FOR THE K2. THE USER HAD TO USE THE BROACH EXTRACTOR FOR A NEW STYLE BROACH TO GET IT OUT OF THE CANAL. THIS CAUSED A DELAY IN THE SURGERY. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.