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

Model Number	TRIMANO BEACH CHAIR KIT
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product history review was performed as required.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to environmental due to damage incurred during shipping.As no further investigation was able to be performed no change in harm was identified.Complaint trending for this event will be performed per wi-(b)(4).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.
Event or Problem Description
On (b)(6) 2022 it was reported by a distributor via sems that an ar-1644 limb positioner sterile packaging was punctured.This was discovered by a nurse before opening in the field with no patient harm.The case was completed with another sterile kit.This was discovered during rib resection procedure on (b)(6) 2022.

• 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: 19529182
• Report Number: 1220246-2024-05684
• Device Sequence Number: 7704188
• Product Code: BWN
• UDI-Device Identifier: 00888867020450
• UDI-Public: 00888867020450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 Model Number: TRIMANO BEACH CHAIR KIT
• Device Catalogue Number: AR-1644
• Device Lot Number: 60486120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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