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

Catalog Number 72200616SR

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Product failed functional testing with intermittent sticking oscillate button.Cause of sticky button is a corroded oscillate button spring.The root cause of sticky button has been determined to be corrosion of the oscillate button assembly.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.

Event Description

It was reported that the device was not engaging.No patient njury reported.

• Brand Name: SVCE REPL MDU CNTRL PWRMX ELITE
• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7107951
• MDR Text Key: 94671306
• Report Number: 1643264-2017-01818
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885556582305
• UDI-Public: (01)00885556582305
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

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 Catalogue Number: 72200616SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1