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 Date 08/20/2019

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device was not working.No back up device was available.No delay or patient injuries were reported.

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 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 relationship, if any, between the subject device and the reported event could not be determined.

Manufacturer Narrative

H3, h6: 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 functional failure could not be reproduced.Product passed functional testing and 6 hour burn-in in enclosed test tower.No faults or errors occurred 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 related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.No containment or corrective actions are recommended at this time.

• 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: 8991638
• MDR Text Key: 165795641
• Report Number: 1643264-2019-00632
• 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,Followup
• Report Date: 01/14/2020

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: 11/19/2019
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 10/17/2019; 01/13/2020
• Supplement Dates FDA Received: 10/18/2019; 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1