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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 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has not had an extension of hospitalization and was able to leave the hospital at the same evening.The liquid was withdrawn by gravity and massage of the knurl.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.
 
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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 Key11313900
MDR Text Key233252116
Report Number1220246-2021-02570
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00888867039377
UDI-Public00888867039377
Combination Product (y/n)N
PMA/PMN Number
K083707
Number of Events Reported1
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 NumberDW ARTHROSCOPY FLUID MANAGEMENT DEV
Device Catalogue NumberAR-6480
Device Lot Number21901082
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/27/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received08/27/2021
Patient Sequence Number1
Patient Outcome(s) Other;
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