MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT, DYONICS 25; ARTHROSCOPE

Catalog Number	7211010
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the pressure of a control unit, dyonics 25 was at 40 and flow at 8; however, the staff noticed a high saline pressure.It was adjusted as the surgery progressed, but the flow remained strong.They had to reduce the pump pressure to 30 mm to finish the procedure.The pump was adjusted to medium flow.The patient's shoulder was very swollen, and the doctor chose not to discharge the patient that day.The procedure was resumed, without any delay, using the same faulty device.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.During visual evaluation no defects were found in the equipment.During technical analysis, it was found that the equipment had pressure measurements below the value specified by the manufacturer.After replacing the pair of sensors and all other tests according to the manufacturer's procedures, the equipment was released for use.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with an electrical component failure.Factors which could have contributed to the failure include pressure transducer malfunction or the latch keeper wear.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: CONTROL UNIT, DYONICS 25
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23821389
• Report Number: 1643264-2025-00413
• Device Sequence Number: 9422989
• Product Code: HRX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 3596010543554
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K171794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Catalogue Number: 7211010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 70 YR
• Patient Sex: Female