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

Model Number	AGHA48
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon performed a bilateral carpal tunnel release surgery.The issue arose after the removal of the skin stitches, leading to the dehiscence of the proximal incision, which ultimately required the axoguard ha+ nerve protector to be prophylactically removed on (b)(6) 2024 to eliminate any potential risks from a foreign body in an infected field.Wound dehiscence can be influenced by various factors, including potential non-compliance with postoperative instructions by the patient.This non-compliance may have allowed bacteria to enter the wound, resulting in an infection.However, there is insufficient evidence to establish a direct link between the reported adverse event of wound complications and the axoguard ha+nerve protector that was intact throughout the postoperative period.
Additional Manufacturer Narrative
A review of the device lot history record indicated that the device was manufactured to specifications.The nonconformances 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 ave; 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: 20668018
• Report Number: 3017860045-2024-00006
• Device Sequence Number: 6907076
• Product Code: JXI
• UDI-Device Identifier: 00850828007145
• UDI-Public: 850828007145
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 09/30/2025
• Device Model Number: AGHA48
• Device Lot Number: LB1560988
• 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: 04/08/2024
• 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