NA 2002-31-000Recalls & reported problems
Depuy (Ireland) · ANTEVERSION OSTEOTOME SMALL · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy small anteversion osteotome is a hand cutting instrument used in hip replacement surgery. The 62 reports mostly describe the blade bending, twisting, dulling, scratching or breaking, often noticed when staff opened the tray or checked the loaner set before an operation, with no effect on the patient. There were no deaths and no injuries. No recalls name 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
- 61
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295080794), received between May 17, 2018 and Apr 30, 2025 — classified as 61 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (24 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 Deformation24
- Failure to Cut17
- Material Twisted/Bent14
- Scratched Material7
- Break6
- Material Integrity Problem5
- Naturally Worn5
- Dull, Blunt3
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient22
- Insufficient Information2
- No Code Available1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BOX CUTTER IS RIGID AND BENT WHERE IT IS SUPPOSED TO CUT.
Patient problems: Insufficient Information
MAUDE report 21938490 ↗MalfunctionApr 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BOX OSTEOTOME WAS BENT AND UNABLE TO BE USED. DISCOVERED WHEN OPENING TRAY PRE-OPERATIVELY BEFORE A TOTAL HIP REPLACEMENT. REMOVED FROM TRAY FOR REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898453 ↗MalfunctionJul 9, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE OSTEOTOME END WAS BENT.
Patient problems: Insufficient Information
MAUDE report 19705713 ↗MalfunctionMay 9, 2024Material Deformation; Material Deformation
CSSD NOTICED LIP OF BOX CHISEL HAS FOLDED OVER AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281364 ↗MalfunctionMar 13, 2024Failure to Cut; Scratched Material; Failure to Cut; Scratched Material
IT WAS REPORTED THAT THE OSTEOTOME IS DULL, DAMAGED. ¿THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.¿ PATIENT STATUS, OUTCOME, CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895058 ↗MalfunctionJan 18, 2024Material Deformation; Material Deformation
ONE OF THE TIPS OF THE ITEM IS BENT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534901 ↗MalfunctionDec 27, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn
IT WAS REPORTED THAT BOX OSTEOTOME THAT HAS A DAMAGED/BLUNT END. IT¿S NOT KNOWN WHEN THIS HAS OCCURRED BUT IS MOST LIKELY AS THE RESULT OF GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18400066 ↗MalfunctionNov 16, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THERE WAS DAMAGE TO BOX CHISEL. CUTTING AREA HAS DENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18155428 ↗MalfunctionApr 21, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT TIP OF BOX OSTEOTOME IS BENT/DAMAGED. CAUSE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16784640 ↗MalfunctionMar 21, 2023Failure to Cut; Failure to Cut
IT WAS REPORTED THE HANDLE IS CRACKED/SPLIT, THE OSTEOTOME IS BLUNT, AND THE END OF THE ROD WHERE THE T-HANDLE ATTACHES IS WORN AND THE HANDLE WILL NOT STAY ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16581689 ↗MalfunctionMar 15, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT SPD STAFF NOTICED BOXED OSTEOTOME WAS BENT AFTER STERILIZING POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16547796 ↗MalfunctionMar 10, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT INSTRUMENTS WERE DAMAGED AND BENT. THE REPORTED ISSUE WAS IDENTIFIED PREOPERATIVELY. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526231 ↗MalfunctionMar 10, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT INSTRUMENTS WERE DAMAGED AND BENT. THE REPORTED ISSUE WAS IDENTIFIED PREOPERATIVELY. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526226 ↗MalfunctionMar 10, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT INSTRUMENTS WERE DAMAGED AND BENT. THE REPORTED ISSUE WAS IDENTIFIED PREOPERATIVELY. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16526093 ↗MalfunctionNov 8, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED THAT THE OSTEOTOME WAS DULL ON CUTTING EDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15755975 ↗MalfunctionJun 24, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT DEVICE IS BENT AND DULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14802887 ↗MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem
INFORMED BY ORTHOTECH OF DAMAGED INSTRUMENT, PART OF CONSIGNED SET, TRAY NUMBER UNKNOWN, NO PT OUTCOMES, RETURNED TO WAREHOUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14800912 ↗MalfunctionFeb 9, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
BOX CHISEL IS DAMAGED. THE SHARP EDGES OF THE CHISEL ARE BLUNT AND MISSHAPEN. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13495897 ↗MalfunctionJan 27, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13366249 ↗MalfunctionJan 21, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE BOX OSTEOTOME WERE DULL AND BENT FROM EXCESSIVE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314804 ↗MalfunctionJan 21, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE BOX OSTEOTOME WERE DULL AND BENT FROM EXCESSIVE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314800 ↗MalfunctionJan 21, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE BOX OSTEOTOME WERE DULL AND BENT FROM EXCESSIVE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314797 ↗MalfunctionJan 21, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE BOX OSTEOTOME WERE DULL AND BENT FROM EXCESSIVE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314794 ↗MalfunctionJan 21, 2022Failure to Cut; Material Deformation; Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE BOX OSTEOTOME WERE DULL AND BENT FROM EXCESSIVE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13314793 ↗MalfunctionNov 30, 2021Failure to Cut; Failure to Cut
BOX OSTEOTOME IS DULL AND DOES NOT CUT INTO FEMORAL BONE ADEQUATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12895935 ↗
Other OSTEOTOME devices
- NA 2598-07-530Depuy (Ireland) · OSTEOTOME86 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
- 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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