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

Model Number 72201092

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that in a routine check the footswitch didn¿t work.There was no patient involvement.

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
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11817094
• MDR Text Key: 250378685
• Report Number: 1643264-2021-01802
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607423
• UDI-Public: 03596010607423
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1