WATSON EXTRACTION SYSTEM
Received Jun 25, 2026 · Event occurred Jun 5, 2026
Report 1818910-2026-10847 · MDR key 25620842
Device
Generic name
Extraction Instrument
Manufacturer
Depuy Ireland - 3015516266Catalog number
17601A
Lot number
PG352571
Product problems
- Material Deformation
Patient
Unknown
- 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. 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 THE TOP OF THE WATSON EXTRACTION SYSTEM DEVICE THAT IS USED TO TURN AND TIGHTEN WOULD NOT TIGHTEN. ACCORDING TO THE REPORTER, IT SEEMED LIKE THE THREADS WERE CROSS THREADED. THE EVENT DID NOT HAPPEN IN SURGERY.