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

Model Number 7211004

Device Problems Leak/Splash (1354); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an acl reconstruction, there was a fluid leakage from the cassette.It was noticed that one of the cassette membranes was missing.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images noted that one transducer membrane is missing on the cassette.The complaint has been confirmed and the root cause has been associated with 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 missing membranes could have caused the fluid leak.

Manufacturer Narrative

D4: expiration date.H4: device manufacture date b5: event description.

Event Description

It was reported that during an acl reconstruction, there was a fluid leakage from the cassette.It was noticed that one of the cassette membranes was missing.The leaked water covered a quantum controller, a dyonics device and a competitor device, which caused an earth leakage.A backup device was available to complete the procedure with no significant delay or other complications.

• Brand Name: DYONICS 25 INFLOW ONLY TUBE SET (3)
• Type of Device: 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: 11420356
• MDR Text Key: 234991977
• Report Number: 1643264-2021-00895
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010543561
• UDI-Public: 03596010543561
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 7211004
• Device Catalogue Number: 7211004
• Device Lot Number: 50897534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1