Torque Shank 54101-80Recalls & reported problems

I.T.S. GmbH · Torque-Shank, T5x80 AO Connector · 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 09120047305478), received between May 17, 2023 and May 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Device problems

Fracture1
Material Twisted/Bent1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMay 17, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT A T5 SCREWDRIVER SHANK BROKE DURING SURGERY. THERE WERE NO DELAYS IN SURGERY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16944603 ↗

Device details

UDI-DI	`09120047305478`
Brand	Torque Shank
Model	54101-80
Company	I.T.S. GmbH
Product code	LRZ · Screwdriver, Surgical
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	Oct 1, 2024

Device type (GMDN): Surgical instrument torque limiter

A small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. 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.

Other Screwdriver, Surgical devices

Torque Shank 54098-80
I.T.S. GmbH · Screwdriver, Surgical
1 report

All Screwdriver, Surgical 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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