N/A 9790913Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSTRUMENT 9790913 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 00721902989636), received between Jul 11, 2024 and Jul 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Break1

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.

MalfunctionJul 11, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTERIOR CERVICAL DISCECTOMY AND FUSION APPLICATION OF PLATE AND L4-5 SPONDY. IT WAS REPORTED THAT THE SCREWDRIVER BROKE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. (B)(6) 2024, EMAIL (REP): ADDITIONAL INFORMATION RECEIVED. HANDLE WILL NOT RATCHET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720694 ↗

Device details

UDI-DI	`00721902989636`
Brand	N/A
Model	9790913
Company	Medtronic Sofamor Danek, Inc.
Product code	HXX · SCREWDRIVER
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 5, 2018

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 · 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.

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