POWER MODULE FOR TRAUMA RECON SYSTEM

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, 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. A VISUAL AND FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE DEVICE. THE FOLLOWING STEPS FAILED: INFORMATION BUTTON AND SELF-TEST CHARGING AND CHECKING OF POWER MODULE IN CHARGER UBC II CHECK LIQUID INDICATOR DURING THE SERVICE EVALUATION THE FOLLOWING FAILURES WERE IDENTIFIED: FUNCTIONAL : LEAK - LIQUID FUNCTIONAL : WILL NOT CHARGE CONCLUSION: FAILURE REPORTED IS CONFIRMED ROOT CAUSE: USER ERROR.

Description of Event or Problem

IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE DEVICE HAD A LIQUID LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.