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

Catalog Number 72200616S

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the handpiece would get hot during the case and randomly stalled.A backup device was available to complete the procedure with no delay or patient injuries.

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 blade 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 corrosion.The complaint was confirmed and the root cause has been determined to be corrosion of the motor and gearbox assembly.A blade 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: SVC REPL MDU HAND CNTRL PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8646649
• MDR Text Key: 146339544
• Report Number: 1643264-2019-00373
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1