LONG CANNULATED NAIL FOR PELVIC C-CLAMP II

Additional Manufacturer Narrative

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. H10 ADDITIONAL NARRATIVE: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE : 02.306.007; LOT NUMBER: 364P773. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 03/09/2021; MANUFACTURING SITE: JABIL BETTLACH. 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.

Additional Manufacturer Narrative

DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: B3: DATE OF EVENT IS AN UNKNOWN DATE IN 2023. D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

DEVICE REPORT FROM FRANCE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT OVER THE COURSE OF MULTIPLE PROCEDURES, THE SYSTEM DID NOT SLIDE AS USUAL. PROGRESSIVELY WITH USE, A PART OF THE SYSTEM GOT JAMMED. SO THERE WAS A FORCED USE ON ONE SIDE. DURING ONE EVENT, AT THE REMOVAL OF THE SYSTEM, THE SIDE THAT USED TO SLIDE NO LONGER SLIDES. THE CONNECTION BETWEEN THE INTERIOR AND EXTERIOR RAILS HAS BEEN DIFFICULT. THE THREADED SLEEVE GOT STUCK IN THE LOWER ARM. THE METAL INSERT SEPARATED FROM THE LOWER ARM. THE SECOND THREADED SLEEVE ALSO SEIZED UP. TO DATE, THE EQUIPMENT IS UNUSABLE. THE SURGEONS HAD TO FORCE TO RELEASE ALL THE PARTS THAT WERE BLOCKED. A SOLUTION HAD TO BE FOUND TO REMOVE THE MATERIAL BLOCKED IN THE PATIENT'S PELVIS. THE SURGEONS HAVE ADOPTED STRATEGIES ALLOWING THE PERFORMANCE OF THE INTERVENTION WITH NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A LONG CANNULATED NAIL FOR PELVIC C-CLAMP II. THIS IS REPORT 4 OF 11 FOR (B)(4).