Watson Extraction System 17401Recalls & reported problems
Depuy (Ireland) · Strike Plate · Class 1
All models of Watson Extraction System (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00197169174014), received between Sep 10, 2025 and Feb 18, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Break1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT THE DOCTOR USED WATSON EXTRACTION SYSTEM TO REMOVE STEM WITH STRIKE PLATE ATTACHMENT. IT WAS REPORTED THAT THE DEVICE WAS USED TO MANUFACTURERS SPECIFIC CAUTIONS, AND THE STRIKE PLATE BROKE OFF THE THREADED EXTRACTION HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377122 ↗MalfunctionDec 1, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WATSON EXTRACTION SLAP HAMMER HAS A METAL BARB NOT ALLOWING STRIKE PLATE TO FIT ON PROPERLY. IT WAS REPORTED THAT THE STRIKE PLATE WAS PROBABLY OK BUT NO WAY TO TELL. THERE WAS NO DELAY, AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23688822 ↗MalfunctionSep 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREE PIECES DON'T WORK TOGETHER ANYMORE. THE THREADS APPEARED TO BE STRIPPED AND THERE WERE BURRS PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017754 ↗MalfunctionSep 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT WATSON EXTRACTION TOOL WAS USED TO REMOVE STEM. THREADS OF WATSON STRIPPED. THERE WAS NO HARM WAS DONE TO PATIENT; ALL PIECES WERE STILL INTACT AND THERE WAS NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016238 ↗
Other Osteotome devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 reports
- NA 2002-31-000Depuy (Ireland) · OSTEOTOME61 reports
- Watson Extraction System 17601Depuy (Ireland) · Osteotome60 reports
- MORELAND 2422-10-000Depuy Orthopaedics, Inc. · OSTEOTOME53 reports
- SIGMA 2024-47-111Depuy (Ireland) · OSTEOTOME43 reports
- Watson Extraction System 17001Depuy (Ireland) · Osteotome41 reports
- CS-PLUS/CSL-PLUS 75002165Smith & Nephew, Inc. · OSTEOTOME35 reports
- NA 2002-25-000Depuy (Ireland) · OSTEOTOME31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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