CORAIL2 ANTERIOR BROACH HANDLE
Received Jun 2, 2026 · Event occurred May 14, 2026
Report 1818910-2026-09557 · MDR key 25360913
Device
Generic name
Hip Instruments : Handles
Manufacturer
Depuy France Sas - 3003895575Catalog number
952212500F
Lot number
SO2028370
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. IT WAS FURTHER REPORTED THAT THE DEVICES WERE FOUND TO BE BROKEN PRIOR TO SHIPMENT. THE EVENT DID NOT OCCUR IN SURGERY.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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.