4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
Received Jun 25, 2026 · Event occurred Jun 2, 2026
Report 8030965-2026-06548 · MDR key 25619019
Device
Product problems
- Break
- Entrapment of Device
Patient
Not reported
- Discomfort
- Foreign Body In Patient
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 DURING THE DRILLING, THE TIP OF THE DRILL BIT FRACTURED IN THE BONE. THE DOCTOR WASN'T CONCERNED AND, DUE TO THE COMPLEXITY OF ITS REMOVAL, DECIDED TO LEAVE IT IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, SOME DISCOMFORT AROSE BECAUSE THE FRACTURED PART HAD TO BE LEFT INSIDE THE BONE.