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

Model Number	TRIMANO BEACH CHAIR KIT
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
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.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 or Problem 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
• 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: 19214563
• Report Number: 1220246-2024-02632
• Device Sequence Number: 8194090
• Product Code: BWN
• UDI-Device Identifier: 00888867020450
• UDI-Public: 00888867020450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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