MAUDE Adverse Event Report: ARTHREX, INC. TRIMANO BEACH CHAIR KIT; MANUAL INSTR, GENERAL SURGICAL

Model Number	TRIMANO BEACH CHAIR KIT
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional 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 device was not returned for evaluation and therefore the alleged complaint event could not be confirmed.The pictures provided showed the discrepancy of expiration date, but it is not possible to confirm the bandages came from the ar-1644.No inventory remains.This was mfg in 2016.Supplier was made aware.The most likely cause for the reported failure can be attributed to a supplier process issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
It was reported that a device kit which expired on sep-2021 contained bandages which expired on sep-2019.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: TRIMANO BEACH CHAIR KIT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19566807
• Report Number: 1220246-2024-06091
• Device Sequence Number: 7097331
• Product Code: BWN
• UDI-Device Identifier: 00888867020450
• UDI-Public: 00888867020450
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: TRIMANO BEACH CHAIR KIT
• Device Catalogue Number: AR-1644
• Device Lot Number: 100354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown