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

Catalog Number	72200616F
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up the motor drive unit was running hot.The procedure was successfully completed without delay using a back-up device.Incident occurred before the procedure; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that there was no physical damage on the exterior of the product.A functional evaluation was performed on the returned device and found a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.These failures have been determined to be related to the reported event.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 no 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 has been 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 could 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: 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: 18809225
• Report Number: 1643264-2024-00135
• Device Sequence Number: 7310843
• Product Code: HAB
• UDI-Device Identifier: 03596010601209
• UDI-Public: 03596010601209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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 Catalogue Number: 72200616F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/09/2024
• 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