NA 03.605.004Recalls & reported problems

Synthes GmbH · ENDPLATE ELEVATOR 20MM WIDTH 430MM · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034712369), received between Nov 13, 2024 and Nov 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Compatibility Problem” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Compatibility Problem1
Material Integrity Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 13, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem
IT WAS REPORTED, THAT ON OCTOBER 31, 2024. THE INSTRUMENT WAS DULL AND NEEDS REPLACEMENTS. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20675339 ↗

Device details

UDI-DI	`10705034712369`
Brand	NA
Model	03.605.004
Catalog no.	03605004
Company	Synthes GmbH
Product code	HTE · ELEVATOR
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 10, 2022

Device type (GMDN): Bone lever/elevator, reusable

A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Other ELEVATOR devices

NA 399.36
Synthes GmbH · ELEVATOR
15 reports
NA 399.48
Synthes GmbH · ELEVATOR
15 reports
NA 399.40
Synthes GmbH · ELEVATOR
9 reports
NA 399.481
Synthes GmbH · ELEVATOR
8 reports
NA 03.133.202
Synthes GmbH · ELEVATOR
3 reports
NA 399.37
Synthes GmbH · ELEVATOR
3 reports
Innomed, Inc. 3450
Innomed, Inc. · Elevator
2 reports
NA 389.56
Synthes GmbH · ELEVATOR
2 reports

All ELEVATOR 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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