MAUDE Adverse Event Report: ARTHREX, INC. TRIMANO FORTIS REUSABLE LEG HOLDER; OPERATING ROOM TABLE ACCESS

Model Number	TRIMANO FORTIS REUSABLE LEG HOLDER
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rivets on the ar-1747-b are loosening at the trimano attachment site.No additional information.
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: TRIMANO FORTIS REUSABLE LEG HOLDER
• Common Device Name: OPERATING ROOM TABLE ACCESS
• 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: 19358624
• Report Number: 1220246-2024-03569
• Device Sequence Number: 6342381
• Product Code: BWN
• UDI-Device Identifier: 00888867290808
• UDI-Public: 00888867290808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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 FORTIS REUSABLE LEG HOLDER
• Device Catalogue Number: AR-1747-B
• Device Lot Number: 38197077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown