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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Pumping Problem (3016)

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Tingling (2171); Numbness (2415)

Event Date 04/19/2017

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 via the patient's legal representative that on (b)(6) 2017 the patient underwent a right knee arthroscopic repair of a torn meniscus, and arthroscopic chondroplasty of the medial and patellofemoral joint, under general anesthesia.The surgery was performed using an automated arthroscopic pump, pneumatic tourniquet, and arthroscopic tools.It was reported that the pump had an issue during the surgery, thereby necessitating that the surgical team stop using it and convert to gravity flow.The pump issue caused difficulties with visualization of the surgical site, difficulties with use of instrumentation, an increased need for tourniquet pressure and other surgical complications.Following the surgery the patient reportedly experienced numbness and weakness in the right foot; and an inability to flex the toes of the right foot.These symptoms were followed by the gradual development of burning and tingling in the sole of the right foot and subsequent pain and burning sensation throughout the right foot.Additionally, numbness of the right foot and weakness in the toe flexors continued.It was also reported that subsequent studies and evaluations indicate that the patient suffered damage to the right tibial nerve.The pump used in the surgery was an arthrex dual wave arthroscopy fluid management device, model ar-6480, lot number unknown.The following devices/instruments were also utilized during the (b)(6) 2017 procedure: ar-6410 main pump tubing, lot 016700; ar-6410 main pump tubing, lot 100192; ar-8350ds dissector, lot 10073658; ar-8400ex excalibur, lot 10084927.There are two ar-6410 main pump tubings noted on the surgery invoice.It is unknown if one or both may have been utilized during the procedure.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 8879450
• MDR Text Key: 153856808
• Report Number: 1220246-2019-01237
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867039377
• UDI-Public: 00888867039377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other