MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL C/U {} DYONICS POWER II; ARTHROSCOPE

Model Number	72200873SR
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that device presented a short circuit with the smell of smoke, before the case and no patient involved.
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.Product failed functional testing with a short circuit error.Complaint of "short circuit" error message and burnt smell was confirmed.Cause of errors is a shorted electronic component on the main digital pcb.Burnt smell was caused by burnt resistor on main pcb.Product passed functional testing with a known good main pcb installed.

• Brand Name: SVCE REPL C/U {} DYONICS POWER II
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7162822
• Report Number: 1643264-2018-00014
• Device Sequence Number: 13816761
• Product Code: HRX
• UDI-Device Identifier: 00885556624197
• UDI-Public: (01)00885556624197
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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: No Information
• Device Model Number: 72200873SR
• Device Catalogue Number: 72200873SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1