MORELAND 2422-33-000Recalls & reported problems
Depuy Orthopaedics, Inc. · MORELAND REV INST U OSTEOTOME 13.5mm 8 IN · Class 1
All models of MORELAND (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295123194), received between Nov 2, 2022 and Dec 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device-Device Incompatibility1
- Failure to Cut1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Scratched Material; Scratched Material
IT WAS REPORTED, THAT THE OSTEOTOMES WERE COMPLETELY DAMAGED, BEFORE THE OPERATION. NO FURTHER INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20887222 ↗MalfunctionJun 24, 2024Break; Failure to Cut; Break; Failure to Cut
IT WAS REPORTED THAT THE OSTEOTOMES WERE NOT FUNCTIONING AND THEY NEED TO BE REPLACED. NO PATIENT AFFECTED, NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601830 ↗MalfunctionNov 2, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THE IMPACTOR HANDLE IS BROKEN. INSTRUMENTS ARE WORN AND UNABLE TO BE ASSEMBLED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15715108 ↗
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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