MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH,VULCAN; ARTHROSCOPE

Catalog Number 815002-01

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

The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records show there are 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.A visual inspection observed a rusted base and chassis, the cable is pulled from the unit exposing wires, and the cable connector is missing its lockring.A functional evaluation revealed the unit does function but would not be able to be locked to a controller due to the missing lockring.The complaint was verified.Factors that could have contributed to the reported event include misalignment of the connector when connecting to the unit receptacle in which excessive force or twisting could cause damage.Internal complaint reference: case-2021-00053529-1.

• Brand Name: FOOTSWITCH,VULCAN
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11817101
• MDR Text Key: 250378966
• Report Number: 1643264-2021-01801
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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 Catalogue Number: 815002-01
• Device Lot Number: 910006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1