MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLOW/OUTFLOW TUBE SET (3); ARTHROSCOPE

Catalog Number	7211005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during an unknown procedure when inserting the single-use kit of the dyonics pump 25 into the control unit, the box was not recognized by the control unit, so it was not usable (they then used a kit with different lot).No patient injury reported.Back-up device was available.Delay greater than 30 minutes 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 record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: DYONICS 25 INFLOW/OUTFLOW TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8362462
• Report Number: 1643264-2019-00129
• Device Sequence Number: 1920926
• Product Code: HRX
• UDI-Device Identifier: 03596010543578
• UDI-Public: 03596010543578
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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 Expiration Date: 06/30/2021
• Device Catalogue Number: 7211005
• Device Lot Number: 50741682
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/03/2019
• Patient Sequence Number: 1