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

Model Number 72200873

Device Problems Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a knee arthroscopy, the dii controller had a short-circuited, it grew very hot with a burning smell.The procedure was completed with a s+n back-up device.Non-significant delay was reported, and no patient complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection found no issues.A functional evaluation revealed a short circuit detected error message in port a, the resistor associated with this port was burned out.No overheating was noted.An unable to retrieve custom settings error message caused by a low battery voltage was also found.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint of overheating was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.The complaint of a short-circuit was confirmed, and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include connecting a hand piece that is still wet from sterilization processing or connecting a shorted out hand piece causing damage to the motor controller pcb.Please refer to the dyonics power ii control system operations/service manual for recommendations on proper cleaning and sterilization processes the complaint of a unable to retrieve custom settings was confirmed, and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a low or dead battery voltage for the custom setting memory chip.This would cause a loss of power to main pcb's ic with the custom settings memory.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.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 14283685
• MDR Text Key: 290792235
• Report Number: 1643264-2022-00160
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607409
• UDI-Public: 03596010607409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1