DEPUY CMW 1G 40G
Received Jun 9, 2026 · Event occurred May 15, 2026
Report 1818910-2026-09896 · MDR key 25447777
Device
Generic name
Bone Cement : Bone Cement
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
3315040
Lot number
5023744
Product problems
- Difficult to Open or Remove Packaging Material
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 THE VIAL DIDN¿T SNAP ON ETCH. GLASS FELL INSIDE THE VIAL. THERE WAS A FIVE MINUTE DELAY. PATIENT WAS NO AFFECTED.