ACTIS BROACH SIZE 7

Description of Event or Problem

ADDITIONAL COMPLAINT FOLLOW-UP PERFORMED, ON 04-10-2026, VIA 2ND FOLLOW-UP PHONE CALL TO THE INITIAL REPORTER, (B)(6), FOR REVIEW OF E-MAIL ATTACHMENT "(B)(4) - ADDITIONAL INSTRUMENT FOLLOW-UP FROM CHICAGO IN MOTION PRODUCT COMPLAINT": IN THE PHONE CALL, THE INITIAL REPORTER PROVIDED FURTHER VERBAL DETAILS DESCRIBING THE FAILURES (IDENTIFIED WITH CIRCLES IN SOME CASES) WITHIN THE PROVIDED PHOTOGRAPHS OF THE 9 INSTRUMENTS. INFORMATION PROVIDED IS AS FOLLOWS, WITH NEW AWARENESS DATE OF 04-10-2026: 1) PRODUCT NAME: FEM/TIB EXTRAC 11X7 3/4 IN PRODUCT CODE: 242102000. "TIP OF INSTRUMENT (CIRCLED IN PHOTOGRAPH) IS CHIPPED/BROKEN OFF". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 2) PRODUCT NAME: PINN GB STRAIGHT GRATER HNDL PRODUCT CODE: 255000140 "SPRING FUNCTION OF THE GRATER HANDLE IS NOT FUNCTIONING CORRECTLY, SO THAT THE DEVICE INTERACTION WITH ANY GRATER REAMER BASKET/HEAD WILL NOT LOCK/WILL NOT HOLD". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 3) PRODUCT NAME: DRIVER PRODUCT CODE: 620510105. "TIP OF THE DRIVER IS BROKEN INTO PIECES". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 4) PRODUCT NAME: ATTUNE MES SIZING/ROT GDE PRODUCT CODE: 254400509. CLARIFIED THE WRITTEN STATEMENT, "DEVICE STILL FUNCTIONAL, JUST THE WHITE FONT NUMBERING KEEPS ON WEARING OUT/NOT VISIBLE, MAKING IT DIFFICULT TO SEE DURING SURGERY". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 5) PRODUCT NAME: HP EXTRACT TIB COMP REMOVER PRODUCT CODE: 201103045. "THE TOP OF INSTRUMENT IS BROKEN OFF (SEE CIRCLED UPRIGHT INSTRUMENT) -- IT SHOULD LOOK LIKE THE ONE LYING ON ITS SIDE NEXT TO THE BROKEN INSTRUMENT (CIRCLED PART IS THE MISSING PART)". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 6) PRODUCT NAME: PINN STRAIGHT CUP IMPACTOR PRODUCT CODE: 221750041. "THE END OF THE CUP IMPACTOR (THE STRIKE SURFACE) HAS BROKEN OFF OF THE IMPACTOR". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 7) PRODUCT NAME: ACTIS BROACH SZ 7 PRODUCT CODE: 201001070. "THE NECK POST ON THE BROACH IS BENT/DEFORMED SO THAT IT GETS STUCK ONTO ANY BROACH HANDLE IT IS ATTACHED TO". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 8) PRODUCT NAME: ATTUNE EM TIBIAL ANKLE CLAMP PRODUCT CODE: 254400001. "ONE OF THE ANKLE PADDLES ON THE ANKLE CLAMP IS BROKEN". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO. 9) PRODUCT NAME: HUMERAL STEM PIN PUNCH PRODUCT CODE: 620101121. "ONE OF THE LONG SPIKES FROM THE HUMERAL STEM PUNCH IS BROKEN OFF AND MISSING". A. WERE THERE ANY FRAGMENTS GENERATED? NO. IF GENERATED, WERE ALL THE PIECES RETRIEVED? NO.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B3, B5. CORRECTED: H6 MEDICAL DEVICE PROBLEM CODE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT ON UPON OFFICE IN HOUSE INSPECTION, IT WAS FOUND THAT THE INSTRUMENT WAS BROKEN. NO PREVIOUS CASES WAS AFFECTED.