4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT

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. PROCODE: ADDITIONAL PRO-CODE: HWC, HRS. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER OCCUPATION IS A J&J SALES REPRESENTATIVE. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON UNKNOWN DATE, AN EVENT OCCURRED WHERE WE DID A NAIL PLATE COMBO, THE FIRST PLATE WAS USED THE CENTRAL FIXED ANGLE SCREW HOLE DID NOT LOCK INTO THE PLATE, WE ENDED UP TAKING OUT THE PLATE AND USING A SECOND ONE OF A LONGER LENGTH. WE ASSEMBLED THE NAIL AND THEN INSERTED THE LM / ML SCREW HOLES AND THE DRILL BIT MISSED THE NAIL, I¿M NOT ENTIRELY SURE IF IT WAS DUE TO THE NOTCH OF THE TKA REPLACEMENT OR BECAUSE OF THE SCREWS FROM THE PLATE DIVERGING THE DRILL BIT. THE 13MM SLEEVE WAS BENT DURING THE CASE AS WELL FROM PUSHING AND THE ENTRY REAMER WAS STUCK IN THE SLEEVE. (B)(4) IS RELATED TO (B)(4). (B)(4) CAPTURES POST-OP. (B)(4) CAPTURES INTRA-OP. THIS COMPLAIN INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).