MAUDE Adverse Event Report: ARTHREX, INC. CONIC OBTR,FOR 4MM SCOPE SHTH; ARTHROSCOPE AND ACCESSORIES

Model Number CONIC OBTR,FOR 4MM SCOPE SHTH

Device Problem Naturally Worn (2988)

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

Event Date 08/09/2021

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 complaint is confirmed.Device was received: ar-3375-4011, batch 1456758, unpackaged.Observation revealed discoloration consistent with rust and pitting along the shaft of the device.The cause of this event is most likely wear due to age.

Event Description

It was reported that there is pitting corrosion with this device.There was no harm for patient, operator or third-party reported.No further information was received.

• Brand Name: CONIC OBTR,FOR 4MM SCOPE SHTH
• 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: 19191212
• MDR Text Key: 341788777
• Report Number: 1220246-2024-02445
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867101616
• UDI-Public: 00888867101616
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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: CONIC OBTR,FOR 4MM SCOPE SHTH
• Device Catalogue Number: AR-3375-4011
• Device Lot Number: 1456758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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