NA 2002-25-000Recalls & reported problems
Depuy (Ireland) · ANTEVERSION OSTEOTOME MEDIUM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy anteversion osteotome is a surgical bone chisel used in hip replacement procedures. The 32 reports mostly describe blades that would not cut, bent or broken metal, and edges found dull or worn — sometimes noticed when staff checked instrument trays or during surgery. No deaths and no injuries were reported. There are no recalls naming this device.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295080770), received between Jul 9, 2018 and Jun 7, 2024 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (11 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
- Failure to Cut11
- Material Deformation8
- Dull, Blunt7
- Naturally Worn6
- Scratched Material4
- Break2
- Material Twisted/Bent2
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient15
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Failure to Cut; Failure to Cut
DURING ROUTINE TOTAL HIP SURGERY, SURGEONS IDENTIFIED THAT THE INSTRUMENTS HAD BECOME DULL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19489958 ↗MalfunctionJun 6, 2024Failure to Cut; Failure to Cut
DURING ROUTINE TOTAL HIP SURGERY, SURGEONS IDENTIFIED THAT THE INSTRUMENTS HAD BECOME DULL. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480558 ↗MalfunctionSep 8, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE OSTEOTOME IS DULL.
Patient problems: Insufficient Information
MAUDE report 17715377 ↗MalfunctionAug 28, 2023Break; Break
IT WAS REPORTED THAT A ANTEVERSION OSTEOTOME MED WAS DAMAGED, INSTRUMENT WAS BROKEN AT EOC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17633648 ↗MalfunctionMar 10, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT WHILE CHECKING TRAYS THE OSTEOTOMES WERE NOTICED TO BE BLUNT AND UNUSABLE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526436 ↗MalfunctionMar 10, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT WHILE CHECKING TRAYS THE OSTEOTOMES WERE NOTICED TO BE BLUNT AND UNUSABLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526394 ↗MalfunctionMar 10, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT WHILE CHECKING TRAYS THE OSTEOTOMES WERE NOTICED TO BE BLUNT AND UNUSABLE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526376 ↗MalfunctionMar 10, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THAT WHILE CHECKING TRAYS THE OSTEOTOMES WERE NOTICED TO BE BLUNT AND UNUSABLE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526325 ↗MalfunctionNov 1, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED IN OSTEOTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15707677 ↗MalfunctionNov 1, 2022Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHARP EDGE IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15707674 ↗MalfunctionMay 21, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
INSTRUMENT NO LONGER ABLE TO BE USED. IT IS BLUNT DUE TO WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465496 ↗MalfunctionAug 3, 2021Failure to Cut; Failure to Cut
THE ITEMS ARE NO LONGER AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12266510 ↗MalfunctionAug 3, 2021Failure to Cut; Failure to Cut
THE ITEMS ARE NO LONGER AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12266509 ↗MalfunctionAug 3, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT HAS A DAMAGED END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12266449 ↗MalfunctionJun 11, 2021Failure to Cut; Failure to Cut
SURGEON USED TWO BOX OSTEOTOMES DURING A HEMIARTHOPLASTY CASE (ONE SMALL AND ONE MEDIUM) AND BOTH WERE DULL AND DIFFICULT TO INSERT INTO BONE. DURING THE SAME CASE WE ALSO HAD AN ISSUE WITH THE CORAIL STANDARD NECK SEGMENT TRIAL AS IT WAS VERY CHALLENGING TO ATTACH TO ANY BROACH. I ALSO TESTED AFTER THE CASE WITH THE KHO AND KLA NECK TRIALS AND THEY ATTACHED VERY SMOOTHLY. NO SURGICAL OR PATIENT ISSUES AND NO SURGICAL DELAY. CASE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11983764 ↗MalfunctionJan 6, 2021Material Deformation; Material Deformation
THE EDGE OF THE ANTEVERSION OSTEOME WAS BENT. THIS WAS DISCOVERED INTRAOPERATIVELY. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11124872 ↗MalfunctionFeb 25, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
NOTIFIED BY CSSD THAT THE SHARP EDGE OF BOX OSTEOTOME IS BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9750635 ↗MalfunctionFeb 20, 2020Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
ONE OF THE BOX OSTEOTOMES (FROM A C-STEM PREP) TRAY HAS BEEN DAMAGED - CUTTING END WORN AND BENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9732320 ↗MalfunctionOct 1, 2019Scratched Material; Scratched Material
MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS/DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141148 ↗MalfunctionOct 1, 2019Scratched Material; Scratched Material
MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS / DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141141 ↗MalfunctionOct 1, 2019Scratched Material; Scratched Material
MDR HAS INDICATED 3X MEDIUM BOX OSTEOTOMES AND 3X RASPS HAVE SEVERAL DINGS / DENTS DUE TO WEAR AND TEAR AND NEED TO BE REPLACED. PRODUCTS ARE NO LONGER FUNCTIONAL AND REPLACEMENTS ARE REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9141139 ↗MalfunctionAug 13, 2019Break; Dull, Blunt; Material Deformation; Naturally Worn; Break; Dull, Blunt; Material Deformation; Naturally Worn
DAMAGED BOX OSTEOTOME - CHIPPED EDGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8889615 ↗MalfunctionAug 12, 2019Dull, Blunt; Dull, Blunt
INSTRUMENT IS NOT SHARPED ENOUGH FOR SURGERIES. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8885235 ↗MalfunctionJul 2, 2019Dull, Blunt; Dull, Blunt
SURGEON MENTIONED THE BOX OSTEOTOME WAS DULL AND REQUESTED TO HAVE IT REPLACED. DATE OF EVENT: (B)(6) 2019. NO DELAY OF CASE, NO EFFECT TO PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES. WERE FRAGMENTS GENERATED? --> NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8751704 ↗MalfunctionAug 24, 2018Dull, Blunt; Dull, Blunt
(B)(6) HOSPITAL HAS REPORTED TO JNJ REPRESENTATIVE INSTRUMENT IS BLUNT. NEEDS SHARPENING. NO OTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7812849 ↗
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
- Watson Extraction System 17201Depuy (Ireland) · Osteotome21 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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