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

Model Number	7211010S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was overpressurizing; therefore, it had an inconsistent pressure.The case was completed with the same device.No patient injuries were reported.
Additional Manufacturer Narrative
Device evaluation: 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 over pressurization could not be reproduced.Product passed functional testing per factory test with no faults or errors.Product passed functional testing during 6 hour burn-in on wet station utilizing low and high pressure and flow settings.Raw and zero transducer readings were normal and well within specs during all functional tests.At no time during functional testing did pump over pressurize, fluctuate, or become intermittent.All functions perform as expected.Pressure and flow readings were normal throughout burn-in on wet station.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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: RFB 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: 7608481
• Report Number: 1643264-2018-00468
• Device Sequence Number: 1623845
• Product Code: HRX
• UDI-Device Identifier: 00885554030822
• UDI-Public: (01)00885554030822
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2018

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: 7211010S3E
• Device Catalogue Number: 7211010F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 06/17/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1