N/A ASY-00112Recalls & reported problems

Integrity Implants Inc. · Self Retaining Screw Driver · 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 00810004721739), received between Oct 24, 2025 and Oct 24, 2025 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1
Material Twisted/Bent1

Patient problems

Insufficient Information1

Recent adverse event reports

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

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 FOUR OF FOUR FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23380717 ↗

Device details

UDI-DI	`00810004721739`
Brand	N/A
Model	ASY-00112
Company	Integrity Implants Inc.
Product code	LXH · Orthopedic Manual Surgical Instrument
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.

Other Orthopedic Manual Surgical Instrument devices

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All Orthopedic Manual Surgical Instrument 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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