AML EXCEL
Received Jun 25, 2026 · Event occurred Jun 8, 2026
Report 1818910-2026-10916 · MDR key 25630889
Device
Generic name
Hip Instruments : Cutting Instruments
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
200149000
Lot number
HW93925
Product problems
- Break
- Material Deformation
Patient
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. H11: ADDITIONAL MANUFACTURER NARRATIVE: 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 DURING STERILE PROCESSING IT WAS OBSERVED THAT SOME OF THE TEETH ON THE CALCAR PLANAR DEVICE WERE DAMAGED. IT WAS REPORTED THAT THE TEETH ON THE CUTTING SURFACE WERE BENT, CHIPPED AND ROLLED ON THEMSELVES. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THERE WAS NO PATIENT OR USER HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.