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

Model Number	7211005
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that when the dyonics 25 inflow/outflow tube set package was opened, the surgeon noticed that the cellophane tape was already attached to inside the sterilization tray and a foreign material similar to dust was found to be sealed in a package, so the staff taped the foreign material to the area where it was found.The procedure was finished with the same device and there was no delay nor other complication reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted there was a piece of the shipping container made of corrugated fiberboard inside the sterile packaging.Functional evaluation was not performed as visual inspection has confirmed the complaint.The complaint has been confirmed.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include transportation and handling of the packaging.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the manufacturing process shows that there are precautions taken to eliminate particulates inside the sterile packaging.

• 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
• MDR Report Key: 11490015
• Report Number: 1643264-2021-01023
• Device Sequence Number: 5424864
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2021

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: 06/01/2023
• Device Model Number: 7211005
• Device Catalogue Number: 7211005
• Device Lot Number: 50885218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1