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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problems Decrease in Suction (1146); Unintended Movement (3026); Noise, Audible (3273)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2020

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.

Event Description

The customer stated the irrigation motor is noisy and has problems with the irrigation side locking lever.Furthermore the device does not hold in place and has a weak suction motor.Update 27-jan-2021: further information were provided that the reported event occurred during a knee arthroscopy on (b)(6) 2020.It was further reported that the patient got a compartment syndrome at the end of the surgery.Update 01-feb-2021 dw: further information were provided that due to the event the patient has not had an extension of hospitalization and was able to leave the hospital at the same evening.The liquid was withdrawn by gravity and massage of the knurl.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-6480, sn n15067c19 pump was received for investigation.Functional testing identified that the locking levers lacked responsiveness, and further visual evaluation identified wear along the outer diameter of both the magnets located on the backs of each lever, as well as the connection points on the front of the door assemblies.The ar-6480, sn n15067c19 was tested with ar-6410 and ar-6430 tubing sets from stock, and it was observed then that the motor was producing a loud noise while running.While the root cause of the noise remains undetermined, a review of the device history record associated with the complaint batch identified that the device has been in service since 2019.No other abnormalities were identified.The remainder of the evaluation was successful.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11313900
• MDR Text Key: 233252116
• Report Number: 1220246-2021-02570
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 21901082
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 08/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other