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

Catalog Number 7211004

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that, during a knee arthroscopy, the dyonics 25 inflow-only tube set had low pressure. The procedure was successfully finished, but it is unknown how since a back-up device was not available. Surgery was not delayed. The patient was not harmed. 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, thus visual inspection and functional testing could not be performed. 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 relationship, if any, between the subject device and the reported event could not be determined. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 9302522
• MDR Text Key: 165795903
• Report Number: 1643264-2019-00765
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 7211004
• Device Lot Number: 50799490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial