MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3); ARTHROSCOPE

Model Number	7211006
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the dyonics 25 pump and/or dyonics 25 tubing ran fluid continuously and did not sense back pressure.It filled the patients quad full of fluid.The surgeon was able to catch the issue and stop the pump.The procedure was completed with non-significant delays using a back-up device that went to gravity.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during surgery, the dyonics 25 pump and/or dyonics 25 tubing ran fluid continuously and did not sense back pressure.It filled the patients quad full of fluid.The surgeon was able to catch the issue and stop the pump.The procedure was completed with non-significant delays using a back-up device that went to gravity.No patient complications were reported.
Additional Manufacturer Narrative
H11: correction on b1 and h1 as serious injury was reported.D4 updated.
Additional Manufacturer Narrative
H2: additional information: h6: health effect - clinical and impact code.H3, h6: the reported device was received for evaluation.It was determined the device did not contribute to the reported event.Visual inspection of the returned device did not identify any issues.Functional evaluation of the device did not reveal any malfunction.Insufficient product identification information was provided and thus a manufacturing record review and complaint history review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 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.Per the complaint details, we are currently unable to rule out user error as a contributing factor to the reported event.The functional evaluation of the device did not reveal any malfunction.Based on the information provided, the procedure was completed with delay of a ¿few minutes,¿ using a back-up device.No patient harm or further complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.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.Factors that could have contributed to the reported event include a failure of a concomitant device.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.No containment or corrective actions are recommended at this time.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (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: 13635255
• Report Number: 1643264-2022-00070
• Device Sequence Number: 2163387
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 7211006
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 50970392
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 03/09/2022; 01/17/2023
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/11/2022; 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown