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

Catalog Number	7205841
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power board has blow rendering the machine inoperable.No backup device was available; therefore, the procedure was not completed as intended.There was a surgical delay greater than 30 minutes; no patient injuries or complications were reported.
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with no power after the power switch was depressed.Cause of power failure is shorted electronic components on the power supply.Reason for electronic component failure is unknown but a shorted out mdu is a possibility.Product passed functional testing with a known good power supply installed.The complaint investigation has concluded the cause of the failure to be a defective electronic component.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.

• Brand Name: DYONICS POWER CONTROL UNIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8322901
• Report Number: 1643264-2019-00095
• Device Sequence Number: 1650310
• Product Code: HRX
• UDI-Device Identifier: 03596010406200
• UDI-Public: 03596010406200
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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 Catalogue Number: 7205841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1