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

Model Number 7205841

Device Problems Display or Visual Feedback Problem (1184); Electrical Shorting (2926); No Apparent Adverse Event (3189)

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

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

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

Event 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 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.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information in b2, b5, h6.Correction in b1 & h1.

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
• Type of Device: 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
• MDR Text Key: 286955097
• Report Number: 1643264-2022-00071
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010406200
• UDI-Public: 03596010406200
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K030196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205841
• Device Catalogue Number: 7205841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male