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

Model Number 72201500

Device Problem Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that, the powermini handpiece with hand controls did not work properly.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit was not recognized which makes it a reportable event.No other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.A functional evaluation was performed and the mdu was not recognized by the control unit when plugged in.The complaint was confirmed and the root cause has been associated with an electrical component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.Factors that could have contributed to the reported event include a failure of the reed switch or damage on the hall board which may contribute to a short circuit.No containment or corrective actions are recommended at this time.

• 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
• MDR Report Key: 11945038
• MDR Text Key: 254463841
• Report Number: 1643264-2021-02077
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621696
• UDI-Public: 03596010621696
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 04/07/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1