Hallu®-FIX 129733NDRecalls & reported problems

Newdeal · The snap-off cannulated screwdriver is used to implant or explant the snap-off 2.7 & 3.0mm screws. It has a specific spanner slotted-like tip with three equidistant threads designed to fit the snap off screw head. · 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 10381780052197), received between Mar 3, 2023 and Mar 3, 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

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.

MalfunctionMar 3, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING PLATE AND SCREWS REMOVAL SURGERY, TWO TEETH ON A CANNULATED SCREWDRIVER BROKE WHEN TRYING TO REMOVE SCREWS AND PLATE. THIS WAS DUE TO THE PLATE AND SCREW BEING WELL FIXED. HOWEVER, THIS DIDN¿T AFFECT THE OUTCOME OF THE SURGERY AND THE SCREWS AND PLATE WERE SUCCESSFULLY REMOVED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479752 ↗

Device details

UDI-DI	`10381780052197`
Brand	Hallu®-FIX
Model	129733ND
Company	Newdeal
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	Feb 6, 2023

Device type (GMDN): Surgical screwdriver, reusable

A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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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