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)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affiliate stated on (b)(6) 2018 that they are returning the device for investigation.When additional information regarding this device becomes available, a supplemental medwatch form will be filed.
Event or Problem Description
A (b)(6) affiliate from (b)(6) received a report on (b)(6) 2018 regarding a cellfina blade.It was reported that after 25 releases, the blade broke.The affiliate stated that there were no disadvantages for the patient.
Additional Manufacturer Narrative
The blade cartridge was returned and evaluated.A visual inspection was performed using 10x magnification under a microscope.A break was observed just above the blade-shaft weld and the blade tip was found to be bent thus confirming the issue.This may be indicative of a collision with a hard surface.However, this condition was unable to be confirmed without the return of the disposable kit ring component for investigation so the root cause of the issue is unknown.A search of the lot complaint history for the device was performed and no other complaints for this reported condition with this lot number were observed.An evaluation of the lot history review found there have been no design changes associated with the cellfina ck1 disposable kit that would have contributed to the reported issue, and all testing requirements were passed prior to release.A review of the complaint trend analysis for the reported issue of "blade breaks" found the trend to be within acceptable levels and will continue to be monitored.No additional information is available at this time.Should additional information become available, a supplemental medwatch will be filed.

• 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: 7640073
• Report Number: 3006560326-2018-00006
• Device Sequence Number: 1899481
• Product Code: OUP
• UDI-Device Identifier: 00840763100537
• UDI-Public: 00840763100537
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 06/13/2018
• Device Model Number: CK-1
• Device Catalogue Number: 5036225
• Device Lot Number: 46401250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1