WATSON EXTRACTION SYSTEM
Received Jun 5, 2026 · Event occurred May 18, 2026
Report 1818910-2026-09764 · MDR key 25414726
Device
Generic name
Extraction Instrument
Manufacturer
Depuy Ireland - 3015516266Catalog number
17401A
Lot number
PG352569
Product problems
- Device-Device Incompatibility
- Material Deformation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PIECES WERE STRIPPED AND WERE UNABLE TO SCREW INTO EACH OTHER. CANNOT BE USED IN SURGERY. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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.