MAUDE Adverse Event Report: ARTHREX, INC. PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT; ARTHROSCOPIC ACCESSORIES

Model Number PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT

Device Problem Break (1069)

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

Event Date 03/26/2021

Event Type  malfunction  

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 related condition is typically caused by applying excessive force while attempting to cut tissue and/or an excessive amount of tissue at one time.Fragments were accounted for and found during investigation/evaluation process.Function test could not be performed due to the related condition.Unrelated, device also has a bent shaft.

Event Description

It was reported that the device is defective due to a broken push rod.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
• Type of Device: ARTHROSCOPIC 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: 19165222
• MDR Text Key: 340854985
• Report Number: 1220246-2024-02255
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867252516
• UDI-Public: 00888867252516
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PNCH, MD 15 UP TP, 3.4 STR, W/FLUSHPORT
• Device Catalogue Number: AR-12350F
• Device Lot Number: 10332452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1