MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLOW/OUTFLOW TUBE SET (3); ARTHROSCOPE

Catalog Number	7211005
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the dyonics 25 tube set was not pressurizing correctly and fluid was over pumped.The procedure was successfully completed with a delay of 5 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection revealed no issues.The reported malfunction was not duplicated during functional testing.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.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 could not be determined since the reported malfunction could not be duplicated during the investigation.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.Internal complaint reference (b)(4).H11 b1: product problem checked.

• Brand Name: DYONICS 25 INFLOW/OUTFLOW TUBE SET (3)
• 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: 18336498
• Report Number: 1643264-2023-00738
• Device Sequence Number: 17827555
• Product Code: HRX
• UDI-Device Identifier: 03596010543578
• UDI-Public: 03596010543578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7211005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male