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

Model Number	7211004
Medical Device Problem Codes	Infusion or Flow Problem (2964); Noise, Audible (3273)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a shoulder arthroscopy, when the 'dyonics 25 inflow tube' was plugged-in into the pump, it made a noise, the pump was not priming correctly and caused inflammation in the patient's joint at the beginning of the case, but it was quickly fixed.The procedure was completed without delay using a smith and nephew backup device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, when the 'dyonics 25 inflow tube' was plugged-in into the pump, it made a noise, the pump was not priming correctly and caused inflammation in the patient's joint at the beginning of the case, but it was quickly fixed.The procedure was completed without delay using a smith and nephew backup device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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.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 no similar reported events.The instructions for use was 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.Smith and nephew has not received the device/relevant clinical information to perform a thorough medical investigation nor to determine a definitive root cause of the reported event.Based on the information provided, the issue was quickly fixed, and the procedure was completed without a delay using a s&n back-up.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.Correction in h6 (health effect - impact code).

• Brand Name: DYONICS 25 INFLOW ONLY 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: 13361225
• Report Number: 1643264-2022-00027
• Device Sequence Number: 19995141
• Product Code: HRX
• UDI-Device Identifier: 03596010543561
• UDI-Public: 03596010543561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: 7211004
• Device Catalogue Number: 7211004
• Device Lot Number: 50970389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown