AUTOBAHN 1257.5036SRecalls & reported problems

Globus Medical, Inc. · AUTOBAHN EVO Retrograde Femoral Nail, 10x360mm, 5°, Ti · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193982498399), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 injury.

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

Migration1

Patient problems

Pain1

Recent adverse event reports

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

InjurySep 25, 2026Migration
It was reported that during patient's follow-up visit on (b)(6) 2026, imagine showed that the distal screw on the proximal end of the nail and the most distal screw on the distal end of the nail wasbacking out. Patient reported symptomatic pain and could "feel it shifting." Both screws were removed during the revision surgery. The surgeon implanted 2 new screws, one in the medial oblique slot and a proximal screw in the lateral to medial slot.
Patient problems: Pain
MAUDE report 50900594 ↗

Device details

UDI-DI	`00193982498399`
Brand	AUTOBAHN
Model	1257.5036S
Company	Globus Medical, Inc.
Product code	JDS · NAIL, FIXATION, BONE
Class	Class 2
FDA submission	K220659
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Arthrodesis intramedullary nail, non-distracting

A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.

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All NAIL, FIXATION, BONE 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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