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. H11 ADDITIONAL NARRATIVE: A VISUAL AND FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE DEVICE. THE FOLLOWING STEPS FAILED: INFORMATION BUTTON & SELF-TEST CHARGING AND CHECKING OF POWER MODULE IN CHARGER UBC II FUNCTION ¿ TEST. SAW ¿ TEST. CHECK LIQUID INDICATOR. DURING THE SERVICE EVALUATION THE FOLLOWING FAILURES WERE IDENTIFIED: FUNCTIONAL : WILL NOT CHARGE. FUNCTIONAL : LED WARNING LIGHT INDICATOR ERROR - SERVICE. FUNCTIONAL : LEAK - LIQUID. CONCLUSION: FAILURE REPORTED IS CONFIRMED. ROOT CAUSE: USER ERROR (3215). ACTION: EXCHANGE, REPLACEMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE POWER MODULE FOR TRAUMA RECON SYSTEM DEVICE WAS LEAKING A LIQUID. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DOES NOT WORK. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.