MAUDE Adverse Event Report: ARTHREX, INC. CWIII ARTHROSCOPY PUMP; ARTHROSCOPE

Model Number CWIII ARTHROSCOPY PUMP

Device Problems Mechanical Problem (1384); Power Conditioning Problem (1474); Defective Component (2292)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 11/09/2019

Event Type  Injury  

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

It was reported that for an ankle arthroscopic washout the arthrex pump ar-6475 was used.During set up, the pump worked fine.In the middle of the procedure, the pump was spinning fast and was intermittently creating very high fluid pressure in the joint.According to the surgeon the pump almost caused a compartment syndrom for the patient.The surgeon stopped using the pump and completed the surgery successfully with the an manual pressure bag.No further information at the moment.Update 16-dec-2019: patient was having ankle arthroscopic washout for septic arthritis.Pressure sensor on fluid management system appears faulty resulting in pump spinning incredibly fast intermittently creating very high fluid pressures in the joint, before the pump shuts down with fault sign.In this case fluid was pumped into anterior compartment of the leg via the lateral portal and almost caused a compartment syndrome.The patient has also suffered increased pain from additional swelling around the ankle but is thankfully neuro-vascular intact.

Manufacturer Narrative

Complaint not confirmed.Visual evaluation on the returned arthroscopy pump revealed no physical damage on the arthroscopy pump.Further review of components, showed no issues with the latch door or tubing connector.An ar-6410 tubing was assembled to the device.The pump was powered on and no error message and/or audible alarm was triggered.Further review of components, showed no issues with the latch door or tubing connector.The results of the clamp test confirmed the pump did alarm and provide an error as intended/expected.Among the most common causes for this type of occurrence, are unplugging and plugging the pressure line connector into the arthroscopy pump, creating a pressure decay on the pump or spiking bags of fluid and allowing that fluid to migrate through the tubing before plugging the pressure line connector into the pump.These conditions can trigger the alarm for pressure fault.

• Brand Name: CWIII ARTHROSCOPY PUMP
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9482874
• MDR Text Key: 173190633
• Report Number: 1220246-2019-01502
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039346
• UDI-Public: 00888867039346
• Combination Product (y/n): N
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other