NA SD314.230Recalls & reported problems

Synthes GmbH · CANNULATED 4.0MM HEXAGONAL SCREWDRIVER/190MM LONG W/QC · Class 1

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982004833), received between Dec 11, 2024 and Sep 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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. 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

Material Twisted/Bent6

Patient problems

No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027695 ↗
MalfunctionSep 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN'T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027662 ↗
MalfunctionSep 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4). (B)(4) WAS CREATED TO CAPTURE THE ADDITIONAL IPS FROM MOTHER COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23026319 ↗
MalfunctionDec 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THREE (3) SCREWDRIVERS WERE STRIPPED AFTER POST OP INSPECTION. FOUR (4) TFNA HYBRID HANDLES WERE REQUESTED TO BE REPLACED. FOUR (4) AIMING ARMS WERE REQUESTED TO BE REPLACED AFTER LAG SCREW MISSING NAIL. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901686 ↗
MalfunctionDec 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THREE (3) SCREWDRIVERS WERE STRIPPED AFTER POST OP INSPECTION. FOUR (4) TFNA HYBRID HANDLES WERE REQUESTED TO BE REPLACED. FOUR (4) AIMING ARMS WERE REQUESTED TO BE REPLACED AFTER LAG SCREW MISSING NAIL. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901612 ↗
MalfunctionDec 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THREE (3) SCREWDRIVERS WERE STRIPPED AFTER POST OP INSPECTION. FOUR (4) TFNA HYBRID HANDLES WERE REQUESTED TO BE REPLACED. FOUR (4) AIMING ARMS WERE REQUESTED TO BE REPLACED AFTER LAG SCREW MISSING NAIL. THERE WAS NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901510 ↗

Device details

UDI-DI	`10886982004833`
Brand	NA
Model	SD314.230
Catalog no.	SD314230
Company	Synthes GmbH
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 28, 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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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.

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