MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE PUMP TUBING W/CONN, 8' LONG; ARTHROSCOPE AND ACCESSORIES

Model Number REDEUCE PUMP TUBING W/CONN, 8' LONG

Device Problem Pressure Problem (3012)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

On 04/20/2022, it was reported by a sales representative via sems that an ar-6485 synergy cw4 arthroscopy pump had an issue.The pressure was misread, and too much fluid was delivered.This was discovered during use with no impact to the patient.Additional information has been requested.On 04/26/2022, the sales representative provided the following information via email: this event occurred during a knee arthroscopy procedure, arthrex tubing was used with the pump, no extravasation occurred and the complaint pump was used to complete the procedure.The sales representative also stated that day over the phone that both tubing systems were discarded by the facility after the procedure.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: REDEUCE PUMP TUBING W/CONN, 8' LONG
• 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: jared engle ; 8009337001
• MDR Report Key: 19119108
• MDR Text Key: 340304125
• Report Number: 1220246-2024-02067
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00888867118027
• UDI-Public: 00888867118027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REDEUCE PUMP TUBING W/CONN, 8' LONG
• Device Catalogue Number: AR-6411
• Device Lot Number: 56292284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2021
• 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