NA ASY-00375Recalls & reported problems

Integrity Implants Inc. · Open Set Screw Final Driver · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810004727779), received between Oct 24, 2025 and Oct 24, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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

Material Twisted/Bent3
Fracture2

Patient problems

Insufficient Information3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent
A DISTRIBUTOR REPORTED THAT THREE LINESIDER DRIVERS HAD TWISTED/FRACTURED TIPS, AND ONE HAD A TWISTED TIP. NO PATIENT, SURGICAL, OR EVENT INFORMATION WAS PROVIDED. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23380647 ↗
MalfunctionOct 24, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
A DISTRIBUTOR REPORTED THAT THREE LINESIDER DRIVERS HAD TWISTED/FRACTURED TIPS, AND ONE HAD A TWISTED TIP. NO PATIENT, SURGICAL, OR EVENT INFORMATION WAS PROVIDED. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23380355 ↗
MalfunctionOct 24, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
A DISTRIBUTOR REPORTED THAT THREE LINESIDER DRIVERS HAD TWISTED/FRACTURED TIPS, AND ONE HAD A TWISTED TIP. NO PATIENT, SURGICAL, OR EVENT INFORMATION WAS PROVIDED. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23380312 ↗

Device details

UDI-DI	`00810004727779`
Brand	NA
Model	ASY-00375
Company	Integrity Implants 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	May 13, 2022

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