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

Model Number	CFD-22202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the product associated with the reported event was not returned, it was not possible to conduct an evaluation of the device.A review of the complaint history for part # cfd-22202 lot # 368581 has revealed that this product is performing as expected, with regard to the reported incident.With the information provided, it was not possible to identify a root cause; however, potential user-related causes of the reported incident include, off-axis drilling, excessive force during implant insertion and improper selection of device.
Event or Problem Description
On january 17th 2023, microaire was notified by the end-user/doctor facility that a patient's brow fell after a brow lift procedure was completed on (b)(6) 2022.The patient was scheduled for an exploration of the surgical site on (b)(6) 2023 and the doctor identified that the endotine implant had broken, there was no patient injury and they will not be returning the broken implaint to microaire for evaluation.

• Brand Name: MICROAIRE ENDOTINE
• Common Device Name: ENDOTINE FOREHEAD, 3.0
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22901
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville VA 22901
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 16296481
• Report Number: 2020601-2023-00002
• Device Sequence Number: 12282647
• Product Code: ODU
• UDI-Device Identifier: 00847399006868
• UDI-Public: 00847399006868
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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: 03/11/2025
• Device Model Number: CFD-22202
• Device Catalogue Number: CFD-22202
• Device Lot Number: 368581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 53 KG