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 Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the powermax elite mdu hand control unit got hot.Procedure completed with a back-up device.It was reported that there was no delay in the procedure nor patient injury associated with this event.

Manufacturer Narrative

Device investigation narrative - one service replacement powermax elite motor drive unit, part number 72200616s was received on june 06, 2016 and confirmed to be serial number (b)(4).A functional evaluation was performed and presented a motor stall error and heating of the hand piece.A visual inspection of the exterior of the device was performed and no damage was observed.Corrosion was observed on the cable assembly connection and gearbox fork assembly.The motor and gearbox could not be removed from the housing for further assessment due to corrosion.A review of the manufacturing records shows that this unit was released to distribution on or about may 16, 2012.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.(b)(4).

• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5744938
• MDR Text Key: 48756651
• Report Number: 1643264-2016-00100
• Device Sequence Number: 1
• Product Code: HAB
• 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: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• 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: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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