MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLW/OUTFLW FORK SUCTN (3); ARTHROSCOPE

Model Number 7211006

Device Problem Increase in Pressure (1491)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use in a shoulder arthroscopy, the "dyonics 25 inflow/outflow fork suction" was over pressurizing the shoulder joint.The procedure was successfully completed without surgical delay using the same device.No patient complications were reported.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection of the exterior of the device did not reveal any issues but after disassembly of the cassette, rusty bearing was found in the impeller.A functional evaluation revealed that the impeller was noisy.There was no issue with the out pressure.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.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.The root cause of the reported event could not be determined.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.Corrected data: a1 should be read in blank.

• Brand Name: DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)
• 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: 13690266
• MDR Text Key: 286954495
• Report Number: 1643264-2022-00077
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543592
• UDI-Public: 03596010543592
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211006
• Device Catalogue Number: 7211006
• Device Lot Number: 50976089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1