ATTUNE REV KEEL PUNCH SZ 9-10
Received Sep 28, 2023 · Event occurred Sep 14, 2023
Report 1818910-2023-19614 · MDR key 17832747
Device
Product problems
- Break
- Material Deformation
- Break
- Material Deformation
Patient
Unknown
- Insufficient Information
- Insufficient Information
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 TEETH ON KEEL PUNCH WERE BENT AND BROKE.