MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT, DYONICS 25; ARTHROSCOPE

Catalog Number 7211010

Device Problem Pressure Problem (3012)

Patient Problem Swelling/ Edema (4577)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during an arthroscopy, the dyonics 25 control unit failed to regulate the pressure in patient knee which caused extreme swelling of patient knee and fluid infiltration (excessive swelling) into patient leg from knee to hip.The procedure was completed with the same faulty device as the device started malfunctioning towards the end of the procedure and there was no surgical delay.No further complications were reported.

Manufacturer Narrative

H10: 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 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.A clinical review states that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.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: CONTROL UNIT, DYONICS 25
• 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: 18818558
• MDR Text Key: 336684340
• Report Number: 1643264-2024-00141
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 03596010543554
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K171794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other