Gridlock Ankle Screw Driver Bit 320-35-003Recalls & reported problems

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

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

Mar 14, 2019Terminated
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Z-0799-2020 · Root cause: Process control · Recall details · FDA record ↗

Device details

UDI-DI	`00812926026893`
Brand	Gridlock Ankle Screw Driver Bit
Model	320-35-003
Company	Trilliant Surgical, LLC
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	Apr 6, 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 Screwdriver devices

DELTA XTEND 2307-92-003
Depuy (Ireland) · SCREWDRIVER
751 reports
EXPEDIUM 279712400
Medos International Sàrl · SCREWDRIVER
551 reports
NA 314.467
Synthes GmbH · SCREWDRIVER
498 reports
N/A 5584111
Medtronic Sofamor Danek, Inc. · SCREWDRIVER
492 reports
QUICKSET 2274-47-000
Depuy (Ireland) · SCREWDRIVER
487 reports
NA 03.130.010
Synthes GmbH · SCREWDRIVER
1 recall422 reports
QUICKSET 2274-63-000
Depuy (Ireland) · SCREWDRIVER
404 reports
EVOS 71175072
Smith & Nephew, Inc. · SCREWDRIVER
336 reports

All Screwdriver 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page