MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT, DYONICS 25; ARTHROSCOPE

Model Number	7211010S
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was failed to start with an error message of system error.The problem occurred during preparation of the surgery.The procedure was completed with a back-up competitor device.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of system error was confirmed.Product failed functional testing with a system error and pump motor error.Cause of errors is a defective electronic component on the motor controller pcb.Product passed functional testing with a known good motor controller pcb installed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.No containment or corrective actions are recommended at this time.

• Brand Name: CONTROL UNIT, DYONICS 25
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 6921501
• Report Number: 1643264-2017-00596
• Device Sequence Number: 18974205
• Product Code: HRX
• UDI-Device Identifier: 03596010555960
• UDI-Public: (01)03596010555960
• Combination Product (Y/N): N
• PMA/510(K) Number: K171794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: 7211010S
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1