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

Catalog Number 72200616S

Device Problems Overheating of Device (1437); Failure to Shut Off (2939)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).No evaluation conducted to date, awaiting receipt of device.

Event Description

It was reported that the hand control would not turn off and became hot before the procedure began.No injuries or procedural complications were noted as a result.

Manufacturer Narrative

One service replacement powermax elite motor drive unit, part number 72200616s was received on april 11, 2017 and confirmed to be serial number (b)(4).Complaint of overheating and motor engage malfunction was confirmed.Cause of overheating and malfunction is a corroded motor/gearbox.The gearbox was found to be jammed and corroded internally.The root cause of this event was identified to be associated with 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 record was performed which confirmed no inconsistencies.

• 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: james gonzales ; 7000 w william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6354322
• MDR Text Key: 68502476
• Report Number: 1643264-2017-00107
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2013
• 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