NA 6020-08-000Recalls & reported problems
Depuy (Ireland) · THIN OSTEOTOME 7mm x 15in 15 DEGREES · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295178347), received between Jan 18, 2023 and Jun 19, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Contamination /Decontamination Problem1
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE MORELAND HANDLES WERE DISINTEGRATING AND OR BECOMING "SLIMY" AFTER DECONTAMINATION AND STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567771 ↗MalfunctionJan 18, 2023Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT IT HAS BEEN DISCOVERED THAT SOME WOODEN HANDLE HAS CHIPPED. ALL WOODEN PIECES WERE THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194704 ↗
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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