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

Model Number TRIMANO BEACH CHAIR KIT

Device Problem Fitting Problem (2183)

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

Event Date 11/11/2021

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.Complaint confirmed.Visual evaluation confirms the perforation line is missing from the camera drape camera holder (p/n: c5706).No damaged was observed on other components.Further evaluation will be perform under an ncr.

Event Description

On 11/15/2021, it was reported by an arthrex employee via sems that an ar-1644 trimano beach chair kit had no perforation in the part through which the adapter of the transparent sterilization cover was passed.This was discovered during a procedure on (b)(6) 2021.Surgeon completed case with a new device and patient was not affected.

• Brand Name: TRIMANO BEACH CHAIR KIT
• Type of Device: 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: 19214563
• MDR Text Key: 341712122
• Report Number: 1220246-2024-02632
• Device Sequence Number: 1
• Product Code: BWN
• UDI-Device Identifier: 00888867020450
• UDI-Public: 00888867020450
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/30/2024

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: TRIMANO BEACH CHAIR KIT
• Device Catalogue Number: AR-1644
• Device Lot Number: 51720839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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