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 11/27/2023

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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a sas surgery the shaver suction worked sporadically.The cassette was inserted correctly.The pump ar-6480 (sn: (b)(6) worked on the outflow side.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 28-nov-2023: it was further clarified that the ip module of the pump or shaver console is at fault.Either the pump has not processed the signal from the shaver console or the shaver console has not sent a signal.

Manufacturer Narrative

Additional information: d9, g3, h6.Complaint is not confirmed.One unpackaged ar-6480 dualwave arthroscopy fluid management system was returned for investigation.The returned device was assembled with a new ar-6411/ar-6421 and ar-6430 arthroscopy pump tubing and was tested and evaluated under normal use conditions.The pump was powered on, and no error messages and no audible alarms were triggered.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.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.Functional testing with the pressure calibrator found no pump pressure issues.The pump was supplied with 100mmhg and 200mmhg of pressure and displayed the correct reading for each.No problem found.The pump was tested with the shaver console, and the device worked as required.No problem found.The outflow was tested and did not find issues with the suction and lavage system or connection of the cassette.No problem found.Visual evaluation did not find any issues with the device.The review of complaint records for serial number (b)(6) shows that the device has no previous complaints.The original warranty seal was present and completed.The manufacturing date of the device is 2021-11-20.No problem found.Refer to investigation photos.Complaint is not confirmed.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18385104
• MDR Text Key: 331498154
• Report Number: 1220246-2023-09595
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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
• Device Lot Number: 22110027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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