DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Received Apr 17, 2026 · Event occurred Mar 17, 2026
Report 8030965-2026-03561 · MDR key 24910453
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 THE DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T WAS BROKEN WITH THE TIP DETACHED AFTER THE TRAY WAS RETURNED FROM STERILE PROCESSING. THE EVENT WAS IDENTIFIED POST-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AS THE DEVICE FAILURE WAS DISCOVERED DURING SET-UP OR CLEANING.