MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE ENDOTINE; ENDOTINE FOREHEAD 3.0

Model Number	CFD-22202
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states that a female patient was implanted with cfd-22202 lot # 374038 on (b)(6) 2022.The patient returned to the clinic for a post-operative appointment on (b)(6) 2023 and the doctor stated that the surgical site did not feel normal.At that time the doctor re-opened the surgical site and identified that the tines of the implant were broken on the implant and the doctor removed the original (complaint) implant and placed another implant within the surgical site.

• Brand Name: MICROAIRE ENDOTINE
• Common Device Name: ENDOTINE FOREHEAD 3.0
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22968
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 16296369
• Report Number: 2020601-2023-00001
• Device Sequence Number: 18015562
• Product Code: ODU
• UDI-Device Identifier: 10847399006865
• UDI-Public: 10847399006865
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2023

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 Expiration Date: 10/13/2025
• Device Model Number: CFD-22202
• Device Catalogue Number: CFD-22202
• Device Lot Number: 374038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Female