MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP, DYONICSPOWERMINI,HAND CONTROLS; SAW, POWERED, AND ACCESSORIES

Model Number 72201500S

Device Problem Overheating of Device (1437)

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

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that the dyonics powermini gearbox clicks, jams and overheats.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection found no issues.A functional evaluation revealed when mdu plugged in it presented a unknown a handpiece error.Overheating , noisy motor and jamming on mdu were not noted during testing.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include failure of a concomitant device.No containment or corrective actions are recommended at this time.

• Brand Name: SVCE REP, DYONICSPOWERMINI,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: 14198016
• MDR Text Key: 290451979
• Report Number: 1643264-2022-00150
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010654823
• UDI-Public: 03596010654823
• 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: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201500S
• Device Catalogue Number: 72201500S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• 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