NA 2421-03-000Recalls & reported problems
Depuy (Ireland) · THIN OSTEOTOME 8mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295122739), received between Nov 9, 2017 and Feb 23, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break11
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient5
- No Information1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT TWO INSTRUMENTS FROM THE MORELAND KNEE TRAY BROKE WHILE TRYING TO REMOVE THE POLYETHYLENE. IT WAS REPORTED THAT ALL BROKEN PARTS WERE FOUND AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414621 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT DURING A REVISION OF A TOTAL KNEE ARTHOPLASTY PROCEDURE ON THE RIGHT KNEE, THE PATIENT'S THIN OSTEO DEVICE BROKE DURING SURGERY AND WAS LOCATED WITHIN THE SURGICAL FIELD. ALL FRAGMENTS WERE ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316632 ↗MalfunctionJan 28, 2026
OSTEOTOME - HAD BROKEN DURING SURGERY AND WAS LOCATED WITHIN THE SURGICAL FIELD, WITH ALL FRAGMENTS ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24198728 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT OSTEOREMEDIES SNAPPED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372493 ↗MalfunctionApr 4, 2022Break; Break
THE INSTRUMENT BROKE INTO TWO PIECES AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13995910 ↗MalfunctionMar 24, 2022Break; Break
THE WHITE HANDLE OSTEOTOME BLADE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13878052 ↗MalfunctionMar 2, 2020Break; Break
THE CHISEL OSTEOTOME BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9775761 ↗MalfunctionSep 13, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE END OF THE OSTEOTOMES ARE BEAT UP. NEEDS REPLACEMENT, SURGERY WAS NOT DELAYED AND NOTHING WAS LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9031917 ↗MalfunctionFeb 14, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF THE THIN OSTEO 8MM X 7 3/4 IN WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8339021 ↗MalfunctionJan 22, 2019Break; Break
THE THIN OSTEOTOME BROKE WHILE CHISELING CEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8267473 ↗MalfunctionMay 14, 2018Break; Break
IT WAS REPORTED THAT THE 3 INSTRUMENTS WERE DAMAGED WHILE TAKING OUT IMPLANTS. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7512082 ↗MalfunctionNov 9, 2017Break; Break
IT WAS REPORTED THAT THE MOORELAND HANDLES WERE BROKEN DURING EXPLANTATION OF DEVICES.
Patient problems: No Information
MAUDE report 7015284 ↗
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.
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