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

Model Number	CFD-23202
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that one (1) of the ultratine (cfd-23202 lot # 360045) broke upon insertion.They were able to use a replacement (cfd-23202 lot # 348147) to successfully complete the surgery.Due to the initial implant breaking this caused a one (1) hour delay.
Additional Manufacturer Narrative
A review of the device history record associated with cfd-23202 lot # 360045 did not identify any anomalies within the manufacturing process which would contribute to this type of failure.This device was manufactured on 05-13-2021, placed into finished goods on 06-21-2021 with an original ship date of 06-21-2021 to the customer.Microaire received the complaint product on 01-21-2022 and within the complaint incident report (cir) the customer indicated that the surgery was delayed/extended by 1 hour.Visual evaluation of the product identified a break at the platform/post interface.The compression flanges are still intact on the post which confirms that the device broke prior to full insertion within the surgical site.Excessive loading/flexure on the platform can create a bending moment that results in fractures/breakage in the platform of the device.This can be a result of interaction with tissue or other surfaces.
Additional Manufacturer Narrative
A review of the device history record associated with cfd-23202 lot # 360045 did not identify any anomalies within the manufacturing process which would contribute to this type of failure.This device was manufactured on 05-13-2021, placed into finished goods on 06-21-2021 with an original ship date of 06-21-2021 to the customer.Microaire received the complaint product on 01-21-2022 and within the complaint incident report (cir) the customer indicated that the surgery was delayed/extended by 1 hour.Visual evaluation of the product identified a break at the platform/post interface.The compression flanges are still intact on the post which confirms that the device broke prior to full insertion within the surgical site.Excessive loading/flexure on the platform can create a bending moment that results in fractures/breakage in the platform of the device.This can be a result of interaction with tissue or other surfaces.
Event or Problem Description
The customer stated that one (1) of the ultratine (cfd-23202 lot # 360045) broke upon insertion.They were able to use a replacement (cfd-23202 lot # 348147) to successfully complete the surgery.Due to the initial implant breaking this caused a one (1) hour delay.

• Brand Name: MICROAIRE ULTRATINE
• Common Device Name: ULTRATINE FOREHEAD 3.0
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks blvd.; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks blvd.; charlottesville VA 22911
• Manufacturer Contact: erin knight ; 3590 grand forks blvd.; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 13514745
• Report Number: 2020601-2022-00001
• Device Sequence Number: 11880644
• Product Code: ODU
• UDI-Device Identifier: 10847399006889
• UDI-Public: 10847399006889
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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: 05/13/2023
• Device Model Number: CFD-23202
• Device Catalogue Number: CFD-23202
• Device Lot Number: 360045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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 Sex: Female