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

Model Number 72200873

Device Problems Overheating of Device (1437); Electrical Shorting (2926); Protective Measures Problem (3015)

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

Event Date 09/04/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, the dii controller was not functioning, when the motor drive unit was plug in to port a it gave the error message "short circuit detected", the same issue happened when plugging into port b.The hand piece was defective due to an intermittent open circuit/or break in the wiring.The controller was extremely warm and a burning smell was noticed.The procedure was completed without delay using a s+n backup device.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 h3,h6: the reported device, used 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 "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in port a only.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.It appears that a shorted hand piece was inserted into unit.The complaint was confirmed and the root cause has been determined to be a defective electronic component.A review of manufacturing records found the device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.

• 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: 10767264
• MDR Text Key: 214104610
• Report Number: 1643264-2020-01664
• 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: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2020
• 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: 09/28/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1