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

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 10/12/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 10/26/2021, it was reported by a sales representative via sems that while the surgeon repeatedly asked for a rinse on the pump ar-6480, during a knee arthroscopy on (b)(6) 2021.The pressure was set at 50mmhg and around the 30 minute mark, the surgeon noticed that the patient¿s knee had ¿blown up¿ and had become increasingly stiff, swollen and unable to be moved freely.The surgeon then aborted the rest of the case, drained the patients knee as best he could, and ended it there.The patient did have a previous traumatic knee injury.Per the sales representative, the patient is doing well and there was no need for a fasciotomy and the patient was unharmed.

Manufacturer Narrative

The complaint was not confirmed.The returned pump was visually inspected and showed no damaged to the unit.Further review of the pump sub-assembly and components showed no issues with the latch door or tubing connector.The warranty seal was broken and the tubing sets used were not returned.The pump was assembled with a new ar-6410 tubing, and then tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The pump was powered on and function as intended with no error message and/or audible alarm triggered.

• 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: 12819032
• MDR Text Key: 280807640
• Report Number: 1220246-2021-03937
• 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: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• 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?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other