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

Catalog Number	72200872
Medical Device Problem Codes	Mechanical Problem (1384); Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.The root cause was associated with a mechanical component failure.Factors that could have contributed to overheating 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.Several corrective actions were taken to reduce the occurrence of this failure.No further actions are required at this time.
Event or Problem Description
It was reported that the mdu was broken.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10 h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed a blade stall error and overheating of the housing.Further evaluation revealed the drive fork was stiff when rotated.The root cause was associated with a mechanical component failure.Factors that could have contributed to overheating 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.Several corrective actions were taken to reduce the occurrence of this failure.No further actions are required at this time.

• Brand Name: MOT DR UNIT HNDCONT POWERMAX ELITE
• 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: 19551569
• Report Number: 1643264-2024-00420
• Device Sequence Number: 20515716
• Product Code: HAB
• UDI-Device Identifier: 03596010618894
• UDI-Public: 03596010618894
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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