MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES

Model Number 72201500

Device Problem Unintended Power Up (1162)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that during a shoulder scope surgery the powermini starts and stops on its own.The procedure was successfully completed without delay using a back-up 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

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 a relationship found between the returned device and the reported incident.Product failed functional testing with blade stall error and overheating.Cause of overheating and errors is a corroded motor/gearbox.The gearbox was found to be jammed.The complaint was confirmed and the root cause has been determined to be corrosion of the motor and gearbox assembly.A blade stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.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 concluded this was a repeat issue.

• Brand Name: DYONICS POWERMINI WITH HAND CONTROLS
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11489620
• MDR Text Key: 240116958
• Report Number: 1643264-2021-01017
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621696
• UDI-Public: 03596010621696
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/24/2021

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 Model Number: 72201500
• Device Catalogue Number: 72201500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1