NA 2421-07-000Recalls & reported problems

Depuy (Ireland) · POINTED OSTEOTOME 6mm · 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 10603295122777), received between Nov 14, 2017 and Nov 25, 2019 — 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.

Most reported problems

Device problems

Break2
Dull, Blunt1
Fracture1

Patient problems

No Consequences Or Impact To Patient2
No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 25, 2019Break; Break
IT WAS REPORTED THAT THE HANDLE BROKE UPON IMPACTION, ALL PIECES WERE RETRIEVED. CRACK DOWN THE SIDE CAUSED IT TO BREAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9368675 ↗
MalfunctionMar 11, 2019Break; Dull, Blunt; Break; Dull, Blunt
IT WAS REPORTED THAT THE TIP IS DULL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8407555 ↗
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 7030448 ↗

Device details

UDI-DI	`10603295122777`
Brand	NA
Model	2421-07-000
Catalog no.	242107000
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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