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

Model Number	7211010S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device calibration was off.There was no back up device available and no patient injury was reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SVCE REPL 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: 7337041
• Report Number: 1643264-2018-00220
• Device Sequence Number: 1544733
• Product Code: HRX
• UDI-Device Identifier: 03596010555960
• UDI-Public: (01)03596010555960
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 7211010S
• Device Catalogue Number: 7211010S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1