1.8MM DRILL BIT/QC/100MM
Received Jun 23, 2026 · Event occurred May 29, 2026
Report 8030965-2026-06469 · MDR key 25597209
Device
Product problems
- Failure to Cut
- Material Deformation
Patient
NA · Male
- 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, SEVERAL PARTS WERE PRESENT, BUT PART SCREWDRIVER SHAFT STARDRIVE®, T8, CYLINDRICAL, WITH GROOVE, SHAFT Ø 3.5 MM WAS MISSING FROM THE EQUIPMENT. DURING THE PROCEDURE, PART SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F DID NOT PROPERLY SECURE THE SCREWS, AND TWO (2) DRILL BIT Ø1.8 L100/75 2FLUTE F/QUICK CO WERE FOUND TO BE DULL AND BENT UPON USE.