MAUDE Adverse Event Report: BIOMET MICROFIXATION VENAPAX XL; Electrosurgical, Cutting & Coagulation & Accessories

Catalog Number	VPX4000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that at the end of surgery, the patient was found to have three full-thickness one-inch thermal burns along the vein harvest path on the left inner thigh following use of an endoscopic vein harvesting device.The burns were identified after drapes were removed.The leg was wrapped with an elastic bandage, and the wounds were documented for ongoing tracking, assessment, and treatment as needed.Attempts have been made and no further information has been provided.

• Brand Name: VENAPAX XL
• Common Device Name: Electrosurgical, Cutting & Coagulation & Accessories
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24670316
• Report Number: 0001032347-2026-00078
• Device Sequence Number: 12025849
• Product Code: GEI
• UDI-Device Identifier: 00888233078986
• UDI-Public: (01)00888233078986(11)250422(10)43LD9645
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K140603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VPX4000
• Device Lot Number: 43LD9645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 176 LB