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

Model Number 72200616S

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

No evaluation conducted to date, awaiting receipt of device.

Event Description

It was reported that during a knee arthroscopy, the mdu was overheating.A smith & nephew backup device was available.No injuries, delay or complications were reported.

Manufacturer Narrative

The device was received for evaluation.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 was removed from the housing and the gearbox was removed from the motor.The gearbox was found to be jammed.The motor passed functional testing.The complaint was confirmed and the root cause has been determined to be corrosion of the gearbox assembly.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.A corrective action has been initiated to mitigate future recurrence of similar events.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; austin, TX 78735
• MDR Report Key: 6898477
• MDR Text Key: 87727882
• Report Number: 1643264-2017-00582
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010565105
• UDI-Public: (01)03596010565105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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
• Device Operator: Health Professional
• Device Model Number: 72200616S
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1