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

Catalog Number	7211006
Medical Device Problem Codes	Device Alarm System (1012); Increase in Pressure (1491); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup, when the dyonics 25 inflow/outflow fork suction was connected to the controller, the pressure built up to 999 mmhg and an "over pressure" alarm was triggered.It is unknown if a backup device was available, and no surgical delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed no issues.A functional evaluation was performed on the returned device and found an "over-pressure" error message with an alarm during operation and the impeller was noisy.Further investigation revealed a failed impeller.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 no 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 a component failure.Factors that could have contributed to the failure include a failed bearing.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H2: corrected information in h6 (medical device problem code).

• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22286996
• Report Number: 1643264-2025-00205
• Device Sequence Number: 8374273
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 3596010543592
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2025

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: 7211006
• Device Lot Number: 51239261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 07/22/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/23/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2024
• 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