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

Model Number	CK1-EU
Medical Device Problem Codes	Physical Property Issue (3008); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested back for evaluation and follow ups regarding the treatment have been made on (b)(6) 2018, and (b)(6) 2018.When additional information regarding this event becomes available, a supplemental medwatch will be filed.This event occurred in (b)(6), although the medwatch form 3500a abbreviates the country as "(b)(6)".(b)(6) is typically the two-letter abbreviation for (b)(6), while at is typically the two-letter abbreviation for (b)(6).
Event or Problem Description
On (b)(6) 2018, the merz affiliate in (b)(4) was made aware of a product problem that occurred in (b)(6).It was reported that the blade from a cellfina disposable kit broke during a treatment requiring retrieval.No additional local anaesthetic was administered nor were sutures required to close the retrieval point.
Additional Manufacturer Narrative
During the initial report, the affiliate indicated that part of the cellfina blade was removed surgically with tiny forceps and no harm occurred to the patient.The physician claimed that there was no bending of the blade and no contact between the blade and the ring of the vacuum handpiece.A review of the images received from the merz affiliate in austria identified a break between the blade and shaft.The blade cartridge and the motor module were returned and evaluated.The break was found to be just above the blade-shaft weld.The blade tip was found to be bent, potentially due to collision with a hard surface but this is unable to be confirmed without the return of the disposable kit ring for investigation.The blade was also determined to have been flexed multiple times.Upon visual inspection of the device using 10 x magnifications under a microscope, it is determined that the blade was returned with no fragments missing.The blade assembly was functionally evaluated by attaching the device to a motor module.The device operated as specified.The returned cellfina motor module was functionally evaluated following 1004307psd rev.I, "product specification, cellfina system".An attempt to power on motor module with a single activation of the on/off button was successful.The reported issue of motor excessive noise was not replicated during testing.An evaluation of the original dhr found no indication of rework, nonconformance, or deviation associated with the manufacturing of this device, however this device was reworked under dev1300 and relabeled cm1e0131 for the european region.This rework did not contribute to the reported issue of this complaint record.These investigation findings indicate that the device was abused/damage by the user, thus the reported device, results, and conclusion codes have been selected accordingly.A follow up from the affiliate on 2/22/2018 stated that the patient is "fine and she is very happy with the cellfina result" indicating that there was no lasting impact from the event.The investigation found that a merz device did not malfunction, however the device did contribute to the event as its original description was that the breakage of the blade required its removal from the patient.No additional investigation or corrective actions are warranted for this complaint.
Event or Problem Description
On 09 feb 2018, the merz affiliate in germany was made aware of a product problem that occurred in austria.It was reported that the blade from a cellfina disposable kit broke during a treatment requiring retrieval.No additional local anaesthetic was administered nor were sutures required to close the retrieval point.

• 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: 7370565
• Report Number: 3006560326-2018-00001
• Device Sequence Number: 785723
• Product Code: OUP
• UDI-Device Identifier: 00840763100537
• UDI-Public: 00840763100537
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2018
• Device Model Number: CK1-EU
• Device Catalogue Number: CK1
• Device Lot Number: 46013651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention