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

Model Number	72200873S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the port a was not working, a short circuit error message occurred.No user injury was reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was no 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 short circuit error was not confirmed.Unit did fail for a system error ¿unable to retrieve custom settings¿.Cause of system error is low battery voltage for custom setting memory chip on main pcb.Battery voltage reads 1.47 volts on a 3 volt battery.This causes a loss of power to main pcb's ic with the custom settings memory.Replaced old battery with a known good battery and control unit passed functional testing with no system errors and unit retained all custom settings.No shorts were found during functional testing.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: SVCE REP, DYONICS POWER II CONTROL UNIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7337823
• Report Number: 1643264-2018-00221
• Device Sequence Number: 19411216
• Product Code: HRX
• UDI-Device Identifier: 03596010615411
• UDI-Public: (01)03596010615411
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

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: Health Professional
• Device Model Number: 72200873S
• Device Catalogue Number: 72200873S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1