Tornier HRS Max ARS10245Recalls & reported problems

Tornier, Inc. · Inserter & Extractor Handle · Class 1

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840338603937), received between Dec 16, 2025 and Dec 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. 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

Device Difficult to Setup or Prepare1
Material Protrusion/Extrusion1
Mechanical Jam1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
DRIVER DID NOT FIT DOWN BROACH HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23820947 ↗
MalfunctionDec 16, 2025Material Protrusion/Extrusion; Mechanical Jam; Material Protrusion/Extrusion; Mechanical Jam
THE LONG DRIVER (ARS742700) WOULD NOT PASS THROUGH THE BROACH HANDLE (ARS10245) DUE TO A PIN ON THE HANDLE PROTRUDING TOO FAR, BLOCKING THE DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23817847 ↗

Device details

UDI-DI	`00840338603937`
Brand	Tornier HRS Max
Model	ARS10245
Company	Tornier, Inc.
Product code	HWA · IMPACTOR
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	Nov 26, 2025

Device type (GMDN): Surgical instrument handle, non-torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.