MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; SAW, POWERED, AND ACCESSORIES

Model Number 72200872

Device Problems Overheating of Device (1437); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that the motor drive unit had inconsistent motor function, motor jammed.No case reported; therefore, there was no patient involvement.As per results of investigation a blade stall error, overheating of the housing a stiff drive fork when rotated were found.

Manufacturer Narrative

H6: the reported device was received for evaluation.A visual inspection revealed a discolored cable.Discolored cable is a cosmetic issue that does not affect device functionality and it is not related to the alleged failure.A functional evaluation revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with a mechanical component failure.Factors that could have contributed to the failure include a blade stall 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.No containment or corrective actions are recommended at this time.

• Brand Name: MOT DR UNIT HNDCONT POWERMAX ELITE
• 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: 17274920
• MDR Text Key: 318700689
• Report Number: 1643264-2023-00344
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200872
• Device Catalogue Number: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• 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