NA 6020-18-000Recalls & reported problems

Depuy (Ireland) · V OSTEOTOME 7mm x 9in · 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 10603295178446), received between Aug 20, 2018 and May 2, 2025 — classified as 3 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break2
Crack1
Material Deformation1

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.

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 21954189 ↗
MalfunctionMar 21, 2023Break; Break
IT WAS REPORTED THAT DEVICE HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16583874 ↗
MalfunctionAug 20, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT UPON INSPECTION OF TRAYS FOUND THAT OSTEOTOME CHIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7797128 ↗

Device details

UDI-DI	`10603295178446`
Brand	NA
Model	6020-18-000
Catalog no.	602018000
Company	Depuy (Ireland)
Product code	HWM · OSTEOTOME
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 28, 2026

Device type (GMDN): Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Other OSTEOTOME devices

NA 2598-07-530
Depuy (Ireland) · OSTEOTOME
86 reports
NA 2002-31-000
Depuy (Ireland) · OSTEOTOME
61 reports
Watson Extraction System 17601
Depuy (Ireland) · Osteotome
60 reports
MORELAND 2422-10-000
Depuy Orthopaedics, Inc. · OSTEOTOME
53 reports
SIGMA 2024-47-111
Depuy (Ireland) · OSTEOTOME
43 reports
Watson Extraction System 17001
Depuy (Ireland) · Osteotome
41 reports
CS-PLUS/CSL-PLUS 75002165
Smith & Nephew, Inc. · OSTEOTOME
35 reports
NA 2002-25-000
Depuy (Ireland) · OSTEOTOME
31 reports

All OSTEOTOME devices →

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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