MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MOT DR UNIT, HNDCONT POWERMAX ELITE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200872

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.A functional evaluation revealed the motor seized.The complaint has been confirmed and a root cause has been associated with a mechanical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include corrosion in the gearbox/motor assembly from cleaning and sterilization methods and the chemicals involved over a period of time.A review of the device history record was performed which confirmed no inconsistencies.

Event Description

It was reported that during an in-service before the procedure, the mdu overheated as soon as it was connected to a dyonics ii controller.No injuries or complications were reported as a result.

• Brand Name: MOT DR UNIT, HNDCONT POWERMAX 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 w william cannon drive; austin, TX 78735
• MDR Report Key: 6678461
• MDR Text Key: 78821644
• Report Number: 1643264-2017-00368
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 72200872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• 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