MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP, DYONICS POWER II CONTROL UNIT; ARTHROSCOPE

Model Number	72200873S
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup the dyonics power ii started smoking.The procedure was successfully completed without delay using a smith and nephew back up device.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B5: updated.H10.H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation was performed on the returned device and a handpiece sensor fault error in port b was found.Port a worked as intended.Further evaluation revealed a burnt resistor.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 found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint of device port a not working wasn't confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.The complaint of smoking was confirmed, and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include connecting a hand piece that is still wet from sterilization processing or connecting a shorted out hand piece causing damage to the motor controller pcb.Please refer to the dyonics power ii control system operations/service manual for recommendations on proper cleaning and sterilization processes.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during setup the dyonics power ii port a was not working and the shaver started smoking out of port b.There was no delay and a smith and nephew back up device was available.There was no patient involvement.
Event or Problem Description
It was reported that during setup the dyonics power ii port a was not working and the shaver started smoking out of port b.The procedure was successfully completed without delay using a smith and nephew back up device.There was no patient involvement.

• Brand Name: SVCE REP, DYONICS POWER II CONTROL UNIT
• Common Device Name: ARTHROSCOPE
• 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: 15636084
• Report Number: 1643264-2022-00379
• Device Sequence Number: 16825437
• Product Code: HRX
• UDI-Device Identifier: 03596010615411
• UDI-Public: 03596010615411
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K062849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72200873S
• Device Catalogue Number: 72200873S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 12/22/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 10/26/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown