10.0MM REAMER HEAD FOR RIA 2 STERILE

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6), 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH RIA2 IN QUESTION. DURING THE SURGERY, THE REAMER HEAD WAS DETACHED INSIDE THE MEDULLARY CAVITY. WHEN THE SURGEON PULLED THE PRODUCT OUT AND CHECKED THE REAMER HEAD, IT WAS FOUND THAT THE WING-SHAPED CONNECTING PART TO THE DRIVE SHAFT WAS BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. THE SURGEON COMMENTED THAT THERE MAY BE A PROCEDURAL ISSUE, HOWEVER, THERE COULD BE A DRIVE SHAFT MALFUNCTION SINCE THE REAMER HEAD WAS DETACHED. THEREFORE, THE SURGEON REQUESTED TO PERFORM AN INSPECTION ON BOTH THE REAMER HEAD AND THE DRIVE SHAFT. NO FURTHER INFORMATION IS AVAILABLE.