MAUDE Adverse Event Report: AXOGEN CORPORATION AXOGUARD HA+ NERVE PROTECTOR; NERVE CUFF

Model Number	AGHA24
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a revision carpal tunnel release surgery on (b)(6) 2024, during which an axoguard ha+ nerve protector was implanted.The patient was reported doing well during her follow-up visit, with stitches being removed on (b)(6) 2024.However, shortly after, she experienced dehiscence of the proximal wound and returned to the clinic on (b)(6) 2024 for evaluation.On (b)(6) 2024, the patient underwent a drainage and washout of the wound for a suspected infection and it was confirmed at that time that the protective covering remained intact, however the axoguard ha+ nerve protector was prophylactically removed to eliminate any potential risks from a foreign body in an infected field.A culture taken from the fluid in the wound identified enterobacter cloacae.Considering the device was intact throughout the postoperative period, it is highly unlikely that it contributed to the wound complication.
Additional Manufacturer Narrative
A review of the device lot history record indicated that the device was manufactured to specifications.The nonconformance's would not have contributed to the occurrence.According to the device lot history record, all devices released for distribution met the final inspection specification and sterilization requirements.This issue appears to be specific to patient wound management rather than related to the product itself.

• Brand Name: AXOGUARD HA+ NERVE PROTECTOR
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): AXOGEN CORPORATION; tampa heights 111 w oak avenue; tampa FL 33602
• Manufacturer (Section G): AXOGEN CORPORATION BURLESON; 300 boone rd ste a3; burleson TX 76028
• Manufacturer Contact: shravani shastry ; tampa heights 111 w oak ave; tampa, FL 33602
• MDR Report Key: 20666085
• Report Number: 3017860045-2024-00007
• Device Sequence Number: 17963414
• Product Code: JXI
• UDI-Device Identifier: 00850828007121
• UDI-Public: 850828007121
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2025
• Device Model Number: AGHA24
• Device Lot Number: LB1513057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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: Required Intervention
• Patient Sex: Unknown