MAUDE Adverse Event Report: ARTHREX, INC. MAIN PUMP TUBING ARTHROSCOPE

Model Number MAIN PUMP TUBING

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 09/17/2021

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 09/17/2021, it was reported by an arthrex employee via sems that a set of ar-6410 main pump tubing did not work, causing the console to display "door open". This was discovered during use in a procedure performed on (b)(6) 2021. The case was completed by using gravity-assisted-pumping techniques with no patient effect reported. Update: case is confirmed to be a significant deviation from procedure consistent with aborted procedure - serious injury. Information on pump requested from re and will be entered as second product line when received. Update: contact with rep continued. Rep claimed the issue resulted from a setting mistake when attempting to use the pump and tubing, and the procedure was completed using another device. The part and serial numbers of the pump used could not be identified. Due to lack of complete information, case will be left as reportable, subject to change if more information is obtained.

• Brand Name: MAIN PUMP TUBING
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12576908
• MDR Text Key: 274910592
• Report Number: 1220246-2021-03751
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 49146491
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/05/2021 Patient Sequence Number: 1