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

Model Number	7211007
Medical Device Problem Codes	Leak/Splash (1354); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up or inspection for an arthroscopy the sealing rings of the dyonics 25 day tube set were missing, so that all the flushing liquid rushed through and got directly into the system.There was a s+n back-up device.No delay was reported, and no patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device noted that the cassette is missing two transducer membranes.Functional evaluation revealed that the device would leak fluids due to the missing transducer membranes.The complaint has been confirmed and the root cause has been associated with a manufacturing error.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 a repeat issue.A review of the manufacturing process shows that an assembly step was not performed.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.

• Brand Name: DYONICS 25 DAY TUBE SET (3)
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11882928
• Report Number: 1643264-2021-01977
• Device Sequence Number: 19754176
• Product Code: HRX
• UDI-Device Identifier: 03596010543608
• UDI-Public: 03596010543608
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 06/30/2023
• Device Model Number: 7211007
• Device Catalogue Number: 7211007
• Device Lot Number: 50887823
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1