MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN TI ANTEGRADE; AUTOBAHN TI ANTEGRADE/RETROGRADE FEMORAL NAIL

Model Number	1190.3036S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.Additional information provided that the patient experienced a post-op fall and non-union.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported there was a revision surgery to replace an autobahn retro femoral nail that had broken post operatively.

• Brand Name: AUTOBAHN TI ANTEGRADE
• Common Device Name: AUTOBAHN TI ANTEGRADE/RETROGRADE FEMORAL NAIL
• 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: 14212929
• Report Number: 3004142400-2022-00060
• Device Sequence Number: 17587328
• Product Code: HSB
• UDI-Device Identifier: 00889095951493
• UDI-Public: 00889095951493
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 1190.3036S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/26/2022
• 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 Sex: Unknown