MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH, EP-1, PEDAL STYLE; ARTHROSCOPE

Model Number	7205396
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up, the footswitch activated the shaver when it was plugged in and wouldn't turn it off unless pedal was unplugged.The footswitch was plugged in again and got foot pedal error message.There was a back-up device available and no delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was received for evaluation.Visual inspection of the returned device did not identify any issues.The reported malfunction was not duplicated during functional testing.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 was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include failure of a concomitant device.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTSWITCH, EP-1, PEDAL STYLE
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15637465
• Report Number: 1643264-2022-00377
• Device Sequence Number: 6373194
• Product Code: HRX
• UDI-Device Identifier: 03596010251961
• UDI-Public: 03596010251961
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• 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,Followup
• Report Date (Section B): 10/11/2023

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: 7205396
• Device Catalogue Number: 7205396
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 10/09/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/12/2022; 10/11/2023
• 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