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

Model Number 7211010

Device Problem Pressure Problem (3012)

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

Event Date 03/12/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an unspecified procedure, the pump started normally when turning on the 'dyonics control unit'.However, when injecting the equipment, there was no circulation when clicking the start button, the pressure did not decrease, it stayed at 999 all the time and beeping.It turned on and off several times and nothing happened.The surgery was resumed with a competitor device.A delay greater than 30min took place and no further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.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 was not confirmed.Factors which could have contributed to the reported event include a defective transducer or crimped inflow tubing.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.H1: type of reportable event.

• 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: 13979931
• MDR Text Key: 288494769
• Report Number: 1643264-2022-00107
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543554
• UDI-Public: 03596010543554
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K171794
• 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
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211010
• Device Catalogue Number: 7211010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2022
• 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 Age: 26 YR
• Patient Sex: Female