MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. AUTOBAHN; AUTOBAHN TI TROCHANTERIC NAIL, 10X230MM, 125°, RIGHT

Model Number	1176.9202S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to remove an autobahn ti trochanteric nail that had broken post operatively.
Additional Manufacturer Narrative
The device was available for evaluation.The nail was returned along with the other implants in the construct, including a lag screw and locking screw.A fracture was observed in the nail at the anterior-superior wall of the distal screw slot.Deformation of material around the slot and on the locking screw are consistent with torsional loading of the nail.The nail fracture appears to have originated at the interface between the locking screw and anterior-medial wall of the nail slot as a result of external rotation of the distal fragment.The crack likely propagated from the anterior-medial corner of the slot to the anterior-lateral corner of the slot.Due to the fracture, the internal slot dimensions could not be verified, but the distal diameter and slot wall thicknesses measure within specification.The surgeon confirmed that the fracture had occurred around 6 weeks post-surgery with the patient immediately weight-bearing as tolerated.There were no complications during nail removal.The cause of nail breakage is likely excessive in vivo torsional loading.Nail fracture due to excessive torsional loads is a known risk.The risk evaluation meets expectations and residual risk has been reduced as far as possible and the benefit of the device outweighs the residual risk.

• Brand Name: AUTOBAHN
• Common Device Name: AUTOBAHN TI TROCHANTERIC NAIL, 10X230MM, 125°, RIGHT
• 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: 19477207
• Report Number: 3004142400-2024-00114
• Device Sequence Number: 6913917
• Product Code: HSB
• UDI-Device Identifier: 00193982504571
• UDI-Public: 00193982504571
• 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: 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
• Report Date (Section B): 06/03/2024

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: 1176.9202S
• Device Lot Number: GBA370MA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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