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

Model Number	1257.8375
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had original surgery for a left distal femur fracture (b)(6) 2026.The patient originally had a 14x380 retrograde sfx nail inserted.At patient's follow-up it was noticed without imaging that one of the distal screws was backing out and pushing against patient's skin; it was confirmed with imaging.During the revision today, the backed-out screw was removed, and an autobahn evo headless screw was inserted.The patient reported no fall or any incident that might have caused additional trauma post initial surgery.
Additional Manufacturer Narrative
Appropriate code: skin distended, there is a visible bump not attributed to inflammation but to the physical presence of something pressing against the skin.The purpose of this rationale is to evaluate the risk associated with post-operative screw backout.The patient reported no fall or incident that might have caused additional trauma after the initial surgery.This patient was treated with a re-operation on (b)(6) 2026, where the backed out headed screw was replaced with a headless screw.This patient was not obese, a non-smoker and non-drinker.The patient age could have potentially affected bone quality and screw purchase in the bone, which may affect screw back-out.The complaint was received with no lot number or physical part, so the dhr and ncmr records could not be reviewed.However, x-rays were provided from the follow-up visit and the revision operation, which confirms the failure mode.In the follow-up visit x-ray, it is confirmed that the most distal 75mm screw was backed off bone and the screw head was pushing against the patient's skin.This was also seen in a photo of the knee where a bump was present from the screw head.The revision x-ray confirms that this patient was treated with a re-operation, where the headed screw was replaced with a headless screw.Based on the risk analysis, it is possible that the screw backed out due to poor screw purchase, poor bone quality, and/or abnormal cyclic loading.However, based on the observations and the information provided, it is not possible to definitively determine the cause of failure.This evaluation determined that this failure did not exceed expected risk; therefore, no further actions will be taken at this time.If the complaint parts are received in the future, the investigation will be reopened at that time.

• 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: 25284399
• Report Number: 3004142400-2026-00108
• Device Sequence Number: 9677904
• Product Code: HSB
• UDI-Device Identifier: 00193982485993
• UDI-Public: 00193982485993
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K220659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 1257.8375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White