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

Model Number	72201092
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that in a routine check the footswitch didn¿t work.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A visual inspection was performed and no deficiencies were observed.A functional test revealed that the left pedal did not function properly.The complaint was verified and the root cause was associated with electrical component failure.Factors, which could have contributed to the reported event include fatigue from repeated bending of the cord during extended use and crushing or shear force induced on the cord inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTSWITCH DYONICS POWER II
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11817094
• Report Number: 1643264-2021-01802
• Device Sequence Number: 3248897
• Product Code: HRX
• UDI-Device Identifier: 03596010607423
• UDI-Public: 03596010607423
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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 Model Number: 72201092
• Device Catalogue Number: 72201092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1