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

Model Number CWIII ARTHROSCOPY PUMP

Device Problem Pressure Problem (3012)

Patient Problem Swelling/ Edema (4577)

Event Date 10/22/2021

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

Event Description

On (b)(6) 2021 it was reported by a sales representative via sems that an ar-6410 pump tubing had an issue during an arthroscopic meniscal repair. The pressure of the pump did not decrease during the operation and swelling occurred in the patient's leg. The swelling of the leg healed after the operation, and no abnormality was found on the postoperative x-ray. It has been reported that the membrane of the product was crushed after the operation. After the leg swelling had recovered, the pump was changed and surgery was resumed.

• Brand Name: CWIII ARTHROSCOPY PUMP
• 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: 12814207
• MDR Text Key: 280805475
• Report Number: 1220246-2021-03920
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CWIII ARTHROSCOPY PUMP
• Device Catalogue Number: AR-6475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/15/2021 Patient Sequence Number: 1