NA 2421-05-000Recalls & reported problems
Depuy (Ireland) · FLAT OSTEOTOME 10mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295122753), received between Nov 14, 2017 and May 2, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Crack1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 21954170 ↗MalfunctionSep 28, 2023Break; Break
IT WAS REPORTED THAT DURING RIGHT KNEE IMPLANT EXPLANT, THE OSTEOTOME BROKE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17833375 ↗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 7650245 ↗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 7030543 ↗
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