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

Model Number	1176.0090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this rationale is to evaluate the risk associated with the identified failure mode of the autobahn ti lag screw, 10.5x90mm (1176.0090) in the autobahn trochanteric nailing system.Based on the provided x-ray image, the lag screw sheared apart at the threads, resulting in a non-union.Based on the risk analysis, it is possible that the set screw could not be controllably backed off from lag screw.However, it is not possible to definitively determine the cause of failure.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a 90mm lag screw broken at base or threads.The older patient arrived to hospital with nonunion and broken lag screw on (b)(6) 2026, requiring a revision surgery.

• Brand Name: AUTOBAHN
• 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: 25522787
• Report Number: 3004142400-2026-00121
• Device Sequence Number: 13401288
• Product Code: HSB
• UDI-Device Identifier: 00193982485870
• UDI-Public: 00193982485870
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1176.0090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/16/2026
• 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
• Patient Weight: 82 KG