MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

Model Number 72200873

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

It was reported the dii controller overheated, it smelled burn, smoke was observed coming from the rear of the case, and also around the screen.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: 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 visual inspection was performed on the product and no issue was observed.Complaint of overheating and odor was confirmed.Product failed functional testing with a short circuit error in both motor drive unit ports.Cause of errors is a defective electronic component on the main digital pcb.Burnt odor was caused by a burnt resistor on main pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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.

• Brand Name: DII CONTROLLER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10397320
• MDR Text Key: 202585222
• Report Number: 1643264-2020-00832
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607409
• UDI-Public: 03596010607409
• Combination Product (y/n): N
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200873
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1