MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH, DYONICS POWER II; ARTHROSCOPE

Catalog Number	72201092
Medical Device Problem Codes	Self-Activation or Keying (1557); Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before surgery, it was noticed that one (1) footswitch dyonics power ii was broken.No additional information was provided.The procedure was performed, without any delay, using a similar s+n back-up product.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device noted a cut on the cord at the strain relief with exposed wires.A functional evaluation revealed the lock button activates the middle pedal.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 was associated with a component failure.Factors which could have contributed to the reported event, include faulty button switches, fatigue from repeated bending of the cord during extended use and crushing or shear force induced on the cord inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FOOTSWITCH, DYONICS POWER II
• 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: 25192925
• Report Number: 1643264-2026-00173
• Device Sequence Number: 12984275
• Product Code: HRX
• UDI-Device Identifier: 03596010607423
• UDI-Public: 3596010607423
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 72201092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• 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 Sex: Unknown