DRIVE SHAFT FOR RIA 2 520MM
Received May 4, 2026 · Event occurred Apr 20, 2026
Report 8030965-2026-04206 · MDR key 25071693
Device
Product problems
- Break
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT SYNREAM REAMING ROD Ø2.5 LONG L1150, DRIVE SHAFT F/RIA 2 L520, AND SYNREAM REAMING ROD Ø2.5 SHORT L950 WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING SURGERY, THE RIA TREE BROKE WHILE TAKING THE GRAFT, AND THE OLIVE-SHAPED GUIDES BENT AND WERE MARKED. SEVERAL GUIDES AND EQUIPMENT WERE NOT PROVIDED BY THE CENTRAL STAFF, AND A MISSING BOX WAS REPORTED. THERE WAS UNCERTAINTY REGARDING THE STERILIZATION STATUS OF THE SYNREAM EQUIPMENT USED EARLIER THAT DAY, AND THE MOTOR HANDLES WERE NOTED TO BE LOOSE. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT.
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.