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

Model Number	7211005
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up for an arthroscopy, when the outer package was opened, the inner package of the dyonics 25 inflow/outflow tube set had a small hole.Surgery was completed without delay using a back-up device instead.There was no patient involvement.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection revealed several small indentions as well as the major indention.From the outside, the major indention looks like it penetrates through.The inside was torn open to show the caps were still secured.This major indention did not puncture through.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.A review of the material specifications found the raw material requirements, and that the certificate of compliance must be included.The root cause has been associated with a quality control deficiency.Factors that could have contributed to the failure include rough handling.No containment or corrective actions are recommended at this time.

• 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: 15949176
• Report Number: 1643264-2022-00465
• Device Sequence Number: 20473443
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

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 Expiration Date: 03/21/2025
• Device Model Number: 7211005
• Device Catalogue Number: 7211005
• Device Lot Number: 51015039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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: Unknown