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U.S. Department of Health and Human Services

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

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ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE Back to Search Results
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.
 
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Brand NameDW ARTHROSCOPY FLUID MANAGEMENT DEV
Type of DeviceARTHROSCOPE
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 Key8879450
MDR Text Key153856808
Report Number1220246-2019-01237
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2019 Patient Sequence Number: 1
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