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

Model Number 72201500

Device Problems Overheating of Device (1437); Mechanical Jam (2983); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the dyonics powermini gearbox had a click, jammed and overheated.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

The reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found bent guide key.Unable to functional test due to bent guide key.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, noisy motor and mechanical jam was not confirmed, and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.Factors which can contribute to overheating include a blade stall/noisy motor condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved.The complaint of damaged connector was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to a damaged connector include excessive force, misalignment, or twisting of the connector during connection/disconnection to a control unit.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: 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
• 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 ; 5123913905
• MDR Report Key: 14197012
• MDR Text Key: 290303917
• Report Number: 1643264-2022-00143
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621696
• UDI-Public: 03596010621696
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2022
• 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: Unknown
• Patient Sequence Number: 1