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

Model Number MAIN PUMP TUBING

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6410 main pump tubing membrane was crushed and the reflux was unstable.This was discovered during use in a procedure.The case was completed by using a new product with no patient harm.

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.

• Brand Name: MAIN PUMP TUBING
• Type of Device: ARTHROSCOPE AND ACCESSORIES
• 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: emily shafer ; 8009337001
• MDR Report Key: 18048896
• MDR Text Key: 327154032
• Report Number: 1220246-2023-08499
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867118010
• UDI-Public: 00888867118010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083707
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAIN PUMP TUBING
• Device Catalogue Number: AR-6410
• Device Lot Number: 67242353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1