NA 2421-04-000Recalls & reported problems
Depuy (Ireland) · THIN OSTEOTOME 12.5mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295122746), received between Oct 13, 2017 and Oct 21, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Crack2
- Bent1
- Dull, Blunt1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
- No Information2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). THE CEMENT OSTEOTOME HAD BROKEN DURING THE KNEE EXTRACTION. ALL BROKEN PIECES WERE IDENTIFIED AND ACCOUNTED FOR. IT WAS STATED THAT THIS WAS "THE FIRST USE OF THIS INSTRUMENT." THE PRODUCT WAS DISPOSED OF IN THE SHARPS CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349125 ↗MalfunctionMay 2, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICES WERE CHIPPED AND CRACKED. IT DIDN'T HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954192 ↗MalfunctionMar 21, 2023Break; Break
IT WAS REPORTED THAT THE TIP BROKE OFF OF THE CHISEL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16581880 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT THE FEMORAL INTRODUCER RED KNOB BROKE OFF. TIP OF CHISEL BROKE OFF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13620225 ↗MalfunctionFeb 10, 2020Crack; Crack
PHENOLIC HANDLE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9689235 ↗MalfunctionDec 7, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE OSTEOTOME WAS CHIPPED DURING CEMENT REMOVAL. UPON INSPECTION OF TORQUE WRENCH, THE BLACK PIECE CAME LOOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8142720 ↗MalfunctionJul 2, 2018Bent; Dull, Blunt; Bent; Dull, Blunt
IT WAS REPORTED THAT THE INSTRUMENT IS BENT AND DULL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7655047 ↗MalfunctionJun 29, 2018Break; Break
IT WAS REPORTED THAT THE TIPS OF THE INSTRUMENTS ARE BROKEN OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7650299 ↗MalfunctionNov 14, 2017Fracture; Fracture
IT WAS REPORTED THAT THE KNEE EXTRACTION INSTRUMENTS WERE EITHER CHIPPED OR DULL AND THE SURGEON ASKED FOR THEM TO BE REPLACED.
Patient problems: No Information
MAUDE report 7030484 ↗MalfunctionOct 13, 2017Break; Break
IT WAS REPORTED THAT THE MOORELAND HANDLE WAS BROKE DURING EXPLANTATION.
Patient problems: No Information
MAUDE report 6947988 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page