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

Model Number	7205841
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electrical Shorting (2926); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, the dyonics power control unit did not work and did not light up.Additionally, the footpedal did not work either when connected to it.The procedure was completed with a significant delay (40 minutes) using an unknown competitor device.No other complications were reported.
Event or Problem Description
It was reported that, during a knee arthroscopy, the dyonics power control unit did not work and did not light up due to an internal short circuit.Additionally, the footpedal did not work either when connected to it.The procedure was completed with a surgical delay of 40min using a competitor handpiece device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in b2, b5, h6.Correction in b1 & h1.
Additional Manufacturer Narrative
H6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DYONICS POWER 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: 13636449
• Report Number: 1643264-2022-00071
• Device Sequence Number: 5201861
• Product Code: HRX
• UDI-Device Identifier: 03596010406200
• UDI-Public: 03596010406200
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7205841
• Device Catalogue Number: 7205841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/04/2022; 03/04/2024
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/10/2022; 03/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male