MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL MINI MOTOR DRIVE UNIT EP-1; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205357SR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device generate heats during the operation.No patient injury reported.
Event or Problem Description
It was reported that before the procedure, device generated heat during operation.There was no patient involvement.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with motor stall error and overheating.Cause of overheating and errors is a corroded motor/gearbox.The motor/gearbox assembly could not be removed from the housing for further assessment due to the design of the mdu.The motor/gearbox for this type of mini mdu is potted inside of the housing and unit is scrapped when the motor/gearbox jams or wears out.A motor stall condition will result in increased current draw from the control unit which will heat the motor and hand piece housing.Factors which can contribute to gearbox corrosion include cleaning and sterilization methods and the chemicals involved.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: SVCE REPL MINI MOTOR DRIVE UNIT EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8068719
• Report Number: 1643264-2018-00866
• Device Sequence Number: 1593839
• Product Code: HAB
• UDI-Device Identifier: 00885556582398
• UDI-Public: 00885556582398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/30/2019

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: 7205357SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 01/04/2019; 04/29/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/04/2019; 01/04/2019; 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1