MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB MDU HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES

Model Number	72200616F
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the motor drive unit was hot.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found broken lanyard.A functional evaluation revealed handpiece sensor fault error.Using a footswitch a blade stall error and overheating of the power cord was found.Further evaluation revealed a defective power cord.It was determined that the power cord has shorted internal wiring.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 confirmed, and the root cause was associated with a short circuit in the power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.The complaint of handpiece sensor fault error was confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include an internal short or component failure of the hall board.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: RFB MDU HAND CNTRL PWRMX EL
• Common Device Name: 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: 13703461
• Report Number: 1643264-2022-00079
• Device Sequence Number: 17501120
• Product Code: HAB
• UDI-Device Identifier: 03596010601209
• UDI-Public: 03596010601209
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: 72200616F
• Device Catalogue Number: 72200616F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown