DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3

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. H11 ADDITIONAL NARRATIVE: ADDED: D9. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE FLUTED END WAS BROKEN. THE BROKEN FRAGMENTS WERE NOT RETURNED FOR INSPECTION. HOWEVER NO POSTOPERATIVE X-RAYS WERE PROVIDED TO CONFIRM THE EMBEDDED DEVICE, THEREFORE THIS ALLEGATION CAN'T BE CONFIRMED. NO OTHER ISSUES WERE OBSERVED. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 WOULD HAVE CONTRIBUTED TO THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 323.062-15. LOT NUMBER: 76971P2. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 05 AUG 2025. MANUFACTURING SITE: JABIL BETTLACH. 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 TWO (2) 2.0 DRILL BITS BROKE IN HUMERUS DURING PROCEDURE. THE BROKEN DRILL BIT WAS LEFT IN THE PATIENT AND THE SURGEON DECIDED TO TAKE NO ACTION ON BROKEN DRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6: PHOTO INVESTIGATION: THE PHOTO INVESTIGATION REVEALED THAT THE TIP OF THE DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 (323.062) HAD BROKEN. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH PHOTO INVESTIGATION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 WOULD CONTRIBUTE TO THE COMPLAINT ABOUT THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN. THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. 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 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. H11 ADDITIONAL NARRATIVE: ADDED: D4 (LOT), D9. CORRECTED: D4 (PRIMARY UDI NUMBER). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 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. H11 ADDITIONAL NARRATIVE: ADDED: H4. CORRECTED: G1. H6: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT THE TIP OF THE DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 (323.062) HAD BROKEN. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH PHOTO INVESTIGATION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3 WOULD CONTRIBUTE TO THE COMPLAINT ABOUT THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 323.062-15. LOT NUMBER: 76971P2. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 05 AUG 2025. MANUFACTURING SITE: JABIL BETTLACH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.