MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN EVO; AUTOBAHN EVO RETROGRADE FEMORAL NAIL, 11X240MM, SFX, TI

Model Number	1257.5124S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to remove a autobahn evo retrograde femoral nail that was found to be backing out post operatively.
Additional Manufacturer Narrative
No part was available for review.No determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The purpose of this rationale is to evaluate the risk associated with locking screw back out.No part was returned for evaluation.This evaluation determined that the reported failure was within expected risk; therefore, no further action will be taken at this time.
Event or Problem Description
It was reported that a revision was needed to remove a autobahn evo retrograde femoral nail that was found to be backing out post operatively.

• Brand Name: AUTOBAHN EVO
• Common Device Name: AUTOBAHN EVO RETROGRADE FEMORAL NAIL, 11X240MM, SFX, TI
• 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: 21038367
• Report Number: 3004142400-2024-00308
• Device Sequence Number: 18056358
• Product Code: HSB
• UDI-Device Identifier: 00193982498627
• UDI-Public: 00193982498627
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2024

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: 1257.5124S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 42 YR
• Patient Sex: Unknown
• Patient Race: White