REAMING ROD / Ø 3.8MM BALL TIP Ø 3.0MM / 950MM - STERILE
Received Apr 17, 2026 · Event occurred Mar 31, 2026
Report 8030965-2026-03560 · MDR key 24910403
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 REAM ROD / 3.8 BALL TIP 3.0 / 950 -S HAD AN ISSUE WHERE THE PLASTIC COVERING OVER EACH END APPEARED TO BE MELTED ONTO THE GUIDE ROD. THE EVENT OCCURRED INTRA-OPERATIVELY. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.