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	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the design history record (dhr) associated with cfd-22202 lot#: 365617 did not identify any anomalies within the manufacturing process which would have caused/contributed to this type of failure.This is the first known complaint that microaire surgical instruments, llc has received for this product # and lot #.Microaire received the complaint products (2 devices) on (b)(6) 2022 for evaluation.Visual evaluation identified that the compression flanges were sheared off of the post of each device.The compression flanges on the device assist with interlocking the device within the surgical site.Within the complaint incident report (cir) the customer states that the "three holes were drilled on each side and the device would not stay seated until a new endotine was used and this caused a 1 hour delay in surgery." on line 10 within the instruction for use (ifu) for the endotine forehead device it states that "the device cannot be removed from the hole and reused." based on the customer's complaint, dhr, cir and product evaluation this failure is likely attributed to an initial off-axis insertion and then further damage was caused to the implants due to the customers multiple attemped insertions.
Event or Problem Description
The customer states that they drilled 3 holes on each side of the patient and the endotine implants would not seat.Used back-up devices and they worked perfectly.

• 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 22911
• Manufacturer Contact: erin knight ; 3590 grand forks boulevard; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 15625052
• Report Number: 2020601-2022-00007
• Device Sequence Number: 6345615
• Product Code: ODU
• UDI-Device Identifier: 00847399006868
• UDI-Public: 00847399006868
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 12/01/2024
• Device Model Number: CFD-22202
• Device Catalogue Number: CFD-22202
• Device Lot Number: 365617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 54 KG