QUICKSET
Received Jun 26, 2026 · Event occurred Jun 4, 2026
Report 1818910-2026-11000 · MDR key 25640529
Device
Product problems
- Material Deformation
Patient
Not reported
- 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 PINNACLE DRILL BITS SIZE: 25MM , 35MM , 30MM WERE FOUND WITH SPIRAL GAPPING IN THE FLEXIBLE DRILL BITS CAUSING THE DRILL TO NOT DRILL APPROPRIATELY. NO PATIENT HARM. PROCEDURE WAS ABLE TO BE COMPLETED WITH A DIFFERENT SIZE FLEXIBLE DRILL BIT. NO DELAY IN CASE.