NA 6020-27-000Recalls & reported problems
Depuy (Ireland) · V OSTEOTOME 7mm x 13in · Class 1
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 10603295178514), received between Jun 4, 2020 and Jun 30, 2025 — classified as 3 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
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT WOODEN HANDLE WAS CHIPPING OFF SMALL PIECES OF WOOD. HOSPITAL ASKING FOR IT TO BE REPLACED. THEY WILL NOT PROCESS IT. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22358442 ↗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 19567766 ↗MalfunctionJun 4, 2020Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN ON SET BY ORTHO NURSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10118714 ↗
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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