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

Catalog Number	7211010S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the dyonics 25 control unit was causing overpressurization of fluid during an acl procedure.A backup device was used to complete the procedure without delay.No patient injury or complications were reported.
Additional Manufacturer Narrative
Complaint of intermittent and fluctuating pressure was reproduced.Product failed pressure test.Pressure readings fluctuated and zero readings were out of spec.Cause of pressure malfunction is defective transducers p1 and p2.Pump passes functional testing with known good transducers installed.The complaint investigation has concluded the cause of the failure to be defective electronic components.

• 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: 6570646
• Report Number: 1643264-2017-00269
• Device Sequence Number: 749182
• Product Code: HRX
• UDI-Device Identifier: 03596010555960
• UDI-Public: (01)03596010555960
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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 Catalogue Number: 7211010S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1