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

Model Number	7211004
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a mpfl repair the dyonics flow rate dropped after 15 minutes of use.The screen on the dyonics 25 machine showed 1.5 l/m in the first 15 minutes and then dropped to 0.3l/m after that.Then the clinical support team tried restarting the machine and got the same result.The issue was completed with a saline bottle using gravity and a delay of less than or equal to 30 min.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 ONLY TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11571646
• Report Number: 1643264-2021-01151
• Device Sequence Number: 3521778
• Product Code: HRX
• UDI-Device Identifier: 03596010543561
• UDI-Public: 03596010543561
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7211004
• Device Catalogue Number: 7211004
• Device Lot Number: 50897532
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention