NA ARS1026500Recalls & reported problems

Tornier, Inc. · 5N-m Torque Limiting Driver · Class 1

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

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 00846832079209), received between Sep 4, 2024 and Nov 25, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Material Deformation1
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.

MalfunctionNov 25, 2024Mechanical Jam; Mechanical Jam
AS REPORTED: "DRIVER HANDLE IS JAMMED AND WILL NOT ACCEPT THE DRIVER BIT." A BACKUP SET WAS AVAILABLE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20774910 ↗
MalfunctionSep 4, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TORQUE LIMITING DRIVER HANDLE HAS A GOUGE IN THE PLASTIC AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136587 ↗

Device details

UDI-DI	`00846832079209`
Brand	NA
Model	ARS1026500
Company	Tornier, Inc.
Product code	HXX · SCREWDRIVER
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	Sep 15, 2023

Device type (GMDN): Surgical instrument handle, 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, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. 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 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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