MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV; ARTHROSCOPE AND ACCESSORIES

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Suction Problem (2170)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

It was reported that the device has a poor suction.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.

Event Description

Update avoe 26-mar-2024.It was confirmed that the error occurred before the surgery and no patient was involved.

Manufacturer Narrative

Additional information: b5, d3, g3, h6.Complaint was not confirmed.The complaint allegation failure of poor suction was unable to be reproduced.One unpackaged ar-6480 dualwave¿ arthroscopy fluid management system serial number (b)(6) was returned for evaluation.The returned device was visually inspected, and it was noted that the housing had cracks and the warranty seal was tampered with.A most likely cause for the cracked housing can be attributed to misuse due to the damage to the device.A most likely cause for the warranty seal that was tampered with can be attributed to misuse due to unauthorized repair attempts potentially performed.The returned device was assembled with an ar-6410 lot# 73988853 pump tubing and was tested and evaluated under normal use conditions to see if the issue reported could be reproduced.The pump was connected to the power and turned on.After selecting the desired pressure, the run button was pressed to start the machine upon letting the pump run for 118 minutes with no issues.No changes in the pressure were noted during the time the machine was tested.During the 118 minutes the device was ran, it was observed that the device had no issues with the suction and functioned as intended.The device was assembled with an ar-6430, lot 69910382, to test the outflow system.No issues were noted after pressing the lavage and then the rinse buttons.During the 118 minutes the device was ran, no problem was observed with the outflow during that time.Pressure fault test: when the pressure was artificially lowered by removing the inlet from the fluid source, an alarm was triggered, and the device stopped.This behavior is expected¿no problem found.A clamping test was performed as defined in the user guide (dfu-0212 rev 1 ¿ section 5.2) to simulate an overpressure failure on the pump and to verify if an error message and/or audible alarm would be triggered.The results of the clamp test indicate that the pump triggered an alarm, and the rollers did stop moving.This behavior is expected¿no problem found.Pressure testing evaluation with the pressure calibrator set at 100 and 200 mmhg gave the pump pressure results of 46 and 91, respectively.These results indicated no problem with pressures.It was noted during the test that the pump motor/rotating parts made a loud noise when running.The cause of this can be attributed to wear and tear of the motor, which is exhibited in the noisy motor and caused by extended usage in the field¿device manufacture date 2014.No problem found.Correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18951501
• MDR Text Key: 338313240
• Report Number: 1220246-2024-01595
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1