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

Model Number 72200873

Device Problem Insufficient Information (3190)

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

Event Date 03/12/2020

Event Type  malfunction  

Event Description

It was reported that during a knee arthroscopy, the dll controller's prongs were broken.The procedure was completed with a significant delay.Although no backup device is reported, there is no information that reasonably suggests a procedure cancellation, change in surgical technique nor use of competitor device occurred.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h2: additional information on b5.

Event Description

It was reported that during a knee arthroscopy, the dll controller's prongs were broken.There was not backup device available, therefore the procedure was cancelled.No patient injury or other complications were reported.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 damaged ports could not be confirmed.Product passed functional testing and 2 hour burn-in in enclosed test tower.Both mdu ports and the footswitch port performed as expected during functional testing.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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.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 6512
• MDR Report Key: 9925546
• MDR Text Key: 186614047
• Report Number: 1643264-2020-00193
• 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,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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: 03/25/2020
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1