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

Model Number 72201500

Device Problems Overheating of Device (1437); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was received for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.There was a relationship found between the returned device and the reported incident. a visual inspection was performed on the exterior of product and no physical damage was observed.No moisture was observed.A functional evaluation revealed a blade stall error.Overheating did not occur during testing.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that 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 or one or more of the motor phases shorting out.No containment or corrective actions are recommended at this time.

Event Description

It was reported that, the gearbox of the "dyonics powermini shaver, with handcontrols" clicked, jammed and overheated.No case reported; therefore, there was no patient involvement.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12602702
• MDR Text Key: 275882694
• Report Number: 1643264-2021-02339
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621696
• UDI-Public: 03596010621696
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201500
• Device Catalogue Number: 72201500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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