MAUDE Adverse Event Report: MINCROAIRE SURGICAL INSTRUMENTS ENDOTINE MIDFACE ST 4.5; SUTURE, ABSORABABLE

Model Number	CFD-060-0197
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per customer, the device would not load correctly and engage the tissue, also it was not in the correct place.It was difficult to remove and required an extra incision.

• Brand Name: ENDOTINE MIDFACE ST 4.5
• Common Device Name: SUTURE, ABSORABABLE
• Manufacturer (Section D): MINCROAIRE SURGICAL INSTRUMENTS; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer Contact: christina weiss ; 3590 grand forks blvd; charlottesville, VA 22911 ; 4349758360
• MDR Report Key: 24537015
• Report Number: 2020601-2026-00001
• Device Sequence Number: 15710080
• Product Code: GAM
• UDI-Device Identifier: 00847399006783
• UDI-Public: (01)00847399006783(11)251020(17)281020(10)435462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CFD-060-0197
• Device Catalogue Number: CFD-060-0197
• Device Lot Number: 435462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 59 KG