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

Model Number	7205396
Medical Device Problem Codes	Unintended Power Up (1162); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during shoulder rotator cuff arthroscopy, the forward button of the footswitch, ep-1, pedal style got stuck, so the shaver was always on.Procedure was resumed, after a non-significant delay (less or equal to 30min), with a back-up device.Patient was not harmed as consequence of this problem.
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 visual inspection was performed on the product and no issue was observed.Complaint of stuck reverse (left) pedal was confirmed.Footswitch failed functional testing using a known good control unit and mdu.The actuator for the reverse pedal is stuck from corrosion buildup and sticks when depressed.The complaint was confirmed and the root cause was determined to be a corroded reverse pedal actuator.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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
• MDR Report Key: 12571701
• Report Number: 1643264-2021-02331
• Device Sequence Number: 11808620
• Product Code: HRX
• UDI-Device Identifier: 03596010251961
• UDI-Public: 03596010251961
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 7205396
• Device Catalogue Number: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1