MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS POWERMINI, WITH HAND CONTROLS; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201500

Device Problems Break (1069); Failure to Cycle (1142); Overheating of Device (1437)

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

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Complaint of overheating was confirmed.Mdu failed for hand piece blade stall error as well as overheating.Cause of errors and overheating is a corroded motor/gearbox.The motor and gearbox could not be removed from the housing for further assessment due to corrosion.A review of the device history record was performed which confirmed no inconsistencies.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.After the evaluation the root cause for the reported issue was determined to be corrosion.

Event Description

It was reported that before the procedure, the handpiece motor was broken, could not rotate, and was overheating.No reported patient injuries.No other complications were noted.

• Brand Name: DYONICS POWERMINI, WITH HAND CONTROLS
• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 6353689
• MDR Text Key: 68503102
• Report Number: 1643264-2017-00106
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

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: 72201500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1