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

Catalog Number 72200873

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that during the surgery the controller cannot keep the window closed.No patient injuries reported.Unknown if there was a delay.Back-up device was not available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.Complaint of window lock malfunction could not be reproduced.Product passed functional testing and 6 hour burn-in in enclosed test tower.Window lock malfunction did not occur during functional testing on both ports.All functions perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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 found no related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.The instructions for use enlist recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

Event Description

It was reported that, during an unknown surgery the controller could not keep the window closed.It is unknown how the procedure was completed as there was not any back-up device available.It is also unknown if surgery was delayed.However, no patient injuries were reported.

• Brand Name: DII CONTROLLER
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 9353407
• MDR Text Key: 167347809
• Report Number: 1643264-2019-00817
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1