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

Model Number 72200616S

Device Problem Sparking (2595)

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

Event Date 09/08/2017

Event Type  malfunction  

Event Description

It was reported the device was sparking during the hip scope.There was a delay of less than thirty minutes and a backup device was available.No injuries or complications were reported as a result.

Event Description

Sparks came from the top of the device (where the blade/burrs are inserted) while there wasn't anything in it.So user immediately unplugged the device and finished the case using a backup device.

Manufacturer Narrative

There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Product failed functional testing with motor stall error and overheating.The complaint was not confirmed and the root cause could not be determined since the reported malfunction of sparking could not be duplicated during the functional testing process.Cause of overheating and errors is a corroded motor/gearbox.Corrosion was observed on the cable assembly.The motor/gearbox assembly could not be removed from the housing for further assessment due to corrosion.The root cause of the identified failure has been determined to be corrosion of the motor and 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 related to corrosion in the motor/gearbox assembly.

• 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 ; 7000 w william cannon drive; austin, TX 78735
• MDR Report Key: 6858285
• MDR Text Key: 86089299
• Report Number: 1643264-2017-00534
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2017

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 10/04/2017
• Supplement Dates FDA Received: 09/19/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1