Watson Extraction System 17001Recalls & reported problems
Depuy (Ireland) · Osteotome Handle · Class 1
Quick summary
This DePuy osteotome handle is the hand-held part of the Watson Extraction System used to separate bone during joint surgery. The 49 reports mostly describe the handle breaking, sometimes splitting into pieces or having the strike plate break off when struck with an impactor, and in several cases the breakage happened outside surgery. No deaths or injuries are reported. There are no recalls naming this device. Reports rose from 12 in the earlier 12 months to 37 in the most recent one.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00197169170016), received between Jan 22, 2025 and Sep 10, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Break” (40 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break40
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721479 ↗MalfunctionSep 3, 2026Break
Handles broke while being impacted to extract a stem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581938 ↗MalfunctionSep 3, 2026Break
Handles broke while being impacted to extract a stem.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50581936 ↗MalfunctionJul 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087088 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT THE STRIKE PLATE BROKE OFF THE WATSON OSTEOTOME HANDLE. ALL PIECES WERE RECOVERED. THERE WAS NO DELAY TO SURGERY. THERE WAS NO PATIENT IMPACT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25549562 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE WELD ON THE STRIKE PLATE BROKE DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330475 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT DURING HIP REVISION, WHILE USING THE WATSON OSTEOTOME HANDLE THE TOP OF THE HANDLE SNAPPED OFF WHEN SURGEON WAS MALLETING IT. ALL PARTS WERE RETRIEVED FROM THE PATIENT. THIS DID NOT CAUSE ANY DELAYS. THE SURGEON REMOVED IT FROM FEMUR AND BROKE THE BLADE ATTACHMENT MECHANISM DOING SO. SO HE WAS NOT ABLE TO REMOVE THE BLADE FROM THE HANDLE TO RETURN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234313 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE SLAP PLATE BROKE OFF THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092821 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE STRIKE PLATE FOR THE OSTEOTOME HANDLE BROKE BEFORE SURGERY, DURING SETUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055685 ↗MalfunctionApr 24, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WATSON EXTRACTION BLADE HANDLE BROKE OFF. THE SLAP PLATE PART CAME OFF AFTER STRIKING IT WITH A MALLET. IT DID NOT EXTEND SURGERY TIME BECAUSE THERE WAS ANOTHER HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24985587 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT WATSON BLADE IMPACT HANDLE BROKE WHILE IMPACTING, NO DELAY IN CASE, ALL PARTS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903447 ↗MalfunctionApr 14, 2026Break
IT WAS REPORTED THAT THE STRIKE PLATE BROKE OFF THE HANDLE WHILE THE SURGEON WAS MALLETING THE HANDLE DURING STEM REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873084 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE STRIKE PLATE CAME OFF THE BLADE HANDLE. THERE WAS NO DELAY OF SURGERY AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697956 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE DRIVING PLATFORM FROM THE WATSON BLADE IMPACTOR WAS BROKEN OFF WHILE IMPACTING THE WATSON BLADE. THE DRIVING PLATFORM SEPARATED FROM THE SHAFT. BOTH PIECES WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT. THERE WAS A THREE MINUTE DELAY. THIS WAS THE FIRST TIME THAT THE HANDLE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641453 ↗MalfunctionMar 18, 2026Break
IT WAS REPORTED THAT WATSON SET 2 BLADE HANDLE STRIKE PLATE BROKE. THERE WAS NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634662 ↗MalfunctionMar 6, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. CAN YOU PLEASE CONFIRM THE LOT NUMBER OF THE REPORTED DEVICE? NO, I CANNOT CONFIRM THE LOT NUMBERS, BUT THE LOT NUMBERS WE HAD WERE PUT ON THE COMPLAINT. B. DID IT BREAK INTO 2 OR MORE PIECES? YES THEY BROKE INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24537815 ↗MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT THE OSTEOTOME HANDLE BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24537795 ↗MalfunctionFeb 20, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP IT WAS OBSERVED THAT THE OSTEOTOME HANDLE OF THE WATSON EXTRACTION TRAY WAS BROKEN BY THE SURGEON. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403263 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INSTRUMENT BROKE. IT WAS REPORTED THAT THE STRIKE PLATE FELL OFF WHEN BEING STRUCK WITH MALLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384556 ↗MalfunctionFeb 13, 2026Break
ADDITIONAL INFORMATION STATES THAT STRIKE PLATE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333185 ↗MalfunctionJan 23, 2026Break
IT WAS REPORTED THAT BROKEN INSTRUMENT. THE HANDLE BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24168406 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT THE STRIKE PLATE ON THE HANDLE THAT CONNECTS TO THE WATSON BLADE BROKE. THE INSTRUMENT BROKE DURING SURGERY AND ALL PIECES WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24134025 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT THE SURGEON WAS USING THE OSTETOME HANDLE FOR THE WATSON OSTEOTOMES. WHILE STRIKING THE OSTEOTOME HANDLE OUT, THE FLAT STRIKE PLATE BROKE OFF THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24129240 ↗MalfunctionJan 7, 2026Break
IT WAS REPORTED THAT DURING SURGERY THE DOCTOR BANGED THE MALLET TOO HARD ON OSTEO HANDLE AND THE END OF IT BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23992969 ↗MalfunctionDec 12, 2025Break; Break
IT WAS REPORTED THAT THE STRIKE PLATE ON THE WATSON HANDLES FOR THE BLADES THEMSELVES BROKE OFF UPON IMPACTION. AS SHOWN IN PICTURES, THE METAL (STRIKE PLATE) JUST RIPPED/CRACKED RIGHT OFF THE HANDLE PIECE AND SPLIT THE INSTRUMENT IN TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23793026 ↗
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
- CS-PLUS/CSL-PLUS 75002165Smith & Nephew, Inc. · OSTEOTOME35 reports
- NA 2002-25-000Depuy (Ireland) · OSTEOTOME31 reports
- Watson Extraction System 17201Depuy (Ireland) · Osteotome21 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.