MAUDE Adverse Event Report: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER THE CELLFINA SYSTEM

Model Number	CK-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the reported device could not be performed as it was discarded by the facility.The cellfina disposable kit lot number associated with this event was provided, and a lot complaint history review of the device found complaint levels on this lot to be less than 1%.A device history review was performed and devices met all requirements.No non-conformance's or other issues were observed that could have contributed to the reported issue.A trend analysis of the reported issue of "blade breaks" showed no signal has occurred within the past 12 months.Attempts to obtain additional information regarding the event were performed on (b)(6) 2019; however, no additional information is available at this time.Should additional information be obtained, a supplemental report will be filed.
Event or Problem Description
A customer reported on (b)(6) 2019 that the blade in two cellfina disposable kits broke about a minute into the procedure.This is report two of two.The blade did not break while inserted into the patient and there was no injury.

• Brand Name: THE CELLFINA SYSTEM
• Common Device Name: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 8579557
• Report Number: 3006560326-2019-00007
• Device Sequence Number: 11172305
• Product Code: OUP
• UDI-Device Identifier: 00840763100827
• UDI-Public: 00840763100827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 11/29/2019
• Device Model Number: CK-1
• Device Catalogue Number: 5036030
• Device Lot Number: 2018011204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1