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

Catalog Number	7211010F
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during set up, the dyonics 25 control unit did not adjust.It was pumping at a high rate and did not adjust according to pressure settings.Pressure was higher than intended.There was a back-up device available, and no delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of the device and no physical damage was observed.A functional evaluation was performed on the returned device and found unit flowrate was out of spec.It is noted the returned device could be adjusted during the functional evaluation.The failure is associated with a well-known failure mode that has been thoroughly investigated in prior complaints.No new information, trends, or patient impact were identified that would warrant further review.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification 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 that could have contributed include a defective transducer or crimped inflow tubing.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: RFB,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: 23187541
• Report Number: 1643264-2025-00325
• Device Sequence Number: 9992433
• Product Code: HRX
• UDI-Device Identifier: 03596010643827
• UDI-Public: 3596010643827
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 7211010F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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 Sex: Unknown