NA SD-FGS-1300-03Recalls & reported problems

Synthes GmbH · TIBIA SCREW REMOVER · Class 1

Data updated Oct 18, 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 10886982311443), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Device-Device Incompatibility1

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.

MalfunctionNov 17, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, REMOVAL OF A FIBULINK WAS BEING PERFORMED. DURING THE REMOVAL PROCEDURE, THE SD DRIVER GOT STUCK INSIDE OF THE HANDLE, MAKING IT UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A TIBIA SCREW REMOVER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18159402 ↗

Device details

UDI-DI	`10886982311443`
Brand	NA
Model	SD-FGS-1300-03
Catalog no.	SDFGS130003
Company	Synthes GmbH
Product code	HWB · EXTRACTOR
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 2, 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 EXTRACTOR 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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