MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CHISEL MICRO VULCAN ANGLED INTEGRATED; ARTHROSCOPE

Model Number	7209645
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during surgery, upon activation by foot pedal, only sound was heard from the console.No rf was seen transferred to targeted tissue from the chisel micro vulcan angled integrated.Nothing happen except for the sound of ¿activation¿ on console.Saline was checked and cables were replug in to try again, but same result as previous.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection did not reveal any malfunction.A functional evaluation revealed the wand was recognized by controller but did not function.No energy could be delivered to the tip.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include a broken electrical connection.No containment or corrective actions are recommended at this time.

• Brand Name: CHISEL MICRO VULCAN ANGLED INTEGRATED
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11183939
• Report Number: 3003604053-2021-00015
• Device Sequence Number: 14468558
• Product Code: HRX
• UDI-Device Identifier: 03596010470461
• UDI-Public: 03596010470461
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K003893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Model Number: 7209645
• Device Catalogue Number: 7209645
• Device Lot Number: 5090505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1