MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN EVO; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number	1257.8345
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this rationale is to evaluate the risk associated with post-operative screw backout and post-operative breakage of the headed screws in the autobahn evo nailing system.A piriformis antegrade nail with a proximal oblique headless screw and two distal headed locking screws were originally implanted on (b)(6) 2026, to treat a midshaft femur fracture.After the patient experienced a "knee buckling episode", x-ray imaging found that the most distal screw was backing out and the more proximal of the distal screws were broken.This patient was treated with a re-operation on (b)(6) 2026, where both distal screws were replaced with new screws.This patient was a smoker and was possibly non-compliant by weight bearing more than the surgeon recommended.The complaint was received with no lot number or physical part, so the dhr and ncmr records could not be reviewed.However, x-rays were provided from the pre-operation, the follow-up visit, and the revision operation which confirms the failure mode.It was confirmed that the original fracture was a midshaft femur and that it was treated with a piriformis antegrade nail.It is also confirmed that the most distal screw was backed off bone and the more proximal of the two distal screws were broken.The revision x-ray confirms that this patient was treated with a re-operation, where the two headed screws were replaced with new screws.For the screw breakage failure mode, based on the risk analysis, it is possible that the screw broke due to excessive in-vivo loading.However, based on the observations and the information provided, it is not possible to definitively determine the cause of failure.This evaluation determined that this failure did not exceed expected risk for both failure modes; therefore, no further actions will be taken at this time.If the complaint parts are received in the future, the investigation will be reopened at that time.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the surgeon inserted evo antegrade nail on (b)(6) 2026 and had to revise on (b)(6) 2026 due to distal screw breakage and screw back out.The most proximal distal screw broke and the most distal screw backed out of nail.The patient had a "knee buckling" episode post operatively.

• Brand Name: AUTOBAHN EVO
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 25284103
• Report Number: 3004142400-2026-00109
• Device Sequence Number: 21224422
• Product Code: HSB
• UDI-Device Identifier: 00193982485870
• UDI-Public: 00193982485870
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1257.8345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown