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

Model Number	7211007
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that during a total knee arthroplasty, the dyonics 25 day tube pumped an extremely large amount of liquid and was extremely loud.The procedure was successfully completed with non-significant delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.Visual inspection of the returned device did not identify any issues.A functional evaluation revealed that the pressure remained within 5 mmhg of the set pressure for a range of 40 mmhg to 150 mmhg.The flow rate remained below the set limit of 2.5 l/min.No pressure or flow issues were observed.The impeller was noisy during operation.The cassette was disassembled and noted corrosion on the impeller bearings.The design of the cassette allows fluid to contact the bearings in the impeller.This cassette is designed to only be used for a single day and corrosion and noisy impellers are expected observations as fluid remains in contact with the bearings over extended periods of time.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed.The reported failure of extremely loud was confirmed and associated with a component failure of the impeller.Factors that could have contributed to the reported event include fluid contacting the bearings for an extended period of time.The reported failure of excessive fluid pumped was not confirmed since the reported malfunction was not duplicated during functional testing.Factors that could have contributed to excessive fluid include cannula selection or device set up.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 25 DAY TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12875250
• Report Number: 1643264-2021-02428
• Device Sequence Number: 4638544
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: 03596010543608
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 05/31/2024
• Device Model Number: 7211007
• Device Catalogue Number: 7211007
• Device Lot Number: 50944133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown