MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN FLUID MANAGEMENT DEVICE; ARTHROSCOPE

Model Number	7211006
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (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.It is unknown if a back-up device was available and if a delay occurred.No patient complications occurred.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).510k no.Updated to unknown.
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 patient's quadriceps full of fluid.The surgeon was able to catch the issue and stop the pump.It is unknown if a back-up device was available and if a surgical delay took place.No further complications occurred.
Additional Manufacturer Narrative
H10, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.The instructions for use were 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.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states that based on insufficient information, a thorough medical assessment could not be performed at this.Should any additional relevant clinical information be provided, this complaint would be re-assessed.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKNOWN FLUID MANAGEMENT DEVICE
• 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: 13689097
• Report Number: 1643264-2022-00076
• Device Sequence Number: 1906261
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 11/27/2023
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/11/2022; 11/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown