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

Model Number	CFD-22202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) associated with part# cfd-22202/lot # 342993 was reviewed and no anomalies were identified during the manufacturing process that would contribute to this type of failure.The device in question was not returned to microaire for evaluation.Evaluation of the complaint product would have provided detailed information regarding whether tines on the device were damaged/broken and if that contributed to the end-user's inability to engage soft tissue with the implant.Potential causes of this failure mode include, off-axis insertion, or improper patient/implant selection.A review of the complaint history for part# cfd-22202/lot# 342993 has revealed one (1) other complaint against this lot; however, it was unrelated to failure the mode presented in the subject complaint.A review of the device history for part# cfd-22202 has revealed that this product is performing as expected with regard to this failure mode.
Event or Problem Description
It was reported that during a hairline lowering surgery, endotine implants were inserted into the patient's skull without any issue; however, they would not successfully latch on to the patient's scalp skin (galeal flap) to complete the hairline lowering.There was no patient injury.The procedure was extended by one hour.

• Brand Name: MICROAIRE ENDOTINE
• Common Device Name: ENDOTINE FOREHEAD 3.0
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks boulevard; charlottesville, va
• MDR Report Key: 9772103
• Report Number: 2020601-2020-00002
• Device Sequence Number: 11580062
• Product Code: HWC
• UDI-Device Identifier: 10847399006865
• UDI-Public: 10847399006865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 09/06/2022
• Device Model Number: CFD-22202
• Device Catalogue Number: CFD-22202
• Device Lot Number: 339605
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 73