MAUDE Adverse Event Report: Globus Medical, Inc. AUTOBAHN; Arthrodesis intramedullary nail, non-distracting

Model Number	1257.8330
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a retrograde nail and multiple headed locking screws were originally implanted.X-rays from (b)(6) 2026 show two screws (most distal screws on the proximal and distal ends) backing out.Revision surgery on (b)(6) 2026 was done to remove and replace those screws.No physcial part was returned.Additionally, no visual inspection could be done to confirm the failure mode.If the part is returned at a future date, the complaint will be reopened for evaluation.Based on the risk analysis, it is possible that the screw backed out due to poor screw purchase, poor bone quality, or abnormal cyclic loading, however based on the lack of a part being returned and no observations, 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.
Event or Problem Description
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.

• Brand Name: AUTOBAHN
• Common Device Name: Arthrodesis intramedullary nail, non-distracting
• 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 ; +1(610)930-1800
• MDR Report Key: 50900594
• Report Number: 3004142400-2026-00203
• Device Sequence Number: 5853189
• Product Code: HSB
• UDI-Device Identifier: 00193982498399
• UDI-Public: 00193982498399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Model Number: 1257.8330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Weight: 150 LB
• Patient Race: White