DRIVE SHAFT FOR RIA 2 520MM
Received Jun 3, 2026 · Event occurred May 10, 2026
Report 8030965-2026-05091 · MDR key 25372849
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
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.