4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
Received Jul 10, 2026 · Event occurred Jun 12, 2026
Report 8030965-2026-07033 · MDR key 25781636
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE PROCEDURE; THE FRAGMENTS WERE RECOVERED. THE SPECIALIST WAS NOT BOTHERED. THE PROCEDURE WAS NOT DELAYED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE OTHER DRILL BIT FROM THE KIT WAS USED.
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.