NA DWD168Recalls & reported problems

Tornier · ALIGNEMENT PIN-SMOOTH · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386943966), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Unspecified Infection1

Recent adverse event reports

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

InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18904123 ↗

Device details

UDI-DI	`03700386943966`
Brand	NA
Model	DWD168
Company	Tornier
Product code	HWE · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 16, 2022

Device type (GMDN): Orthopaedic bur, reusable

A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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