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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/06/2025, it was reported by a facility representative via (b)(4) that an ar-1747-b trimano fortis reusable leg holder had a rivet break and was bent.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is confirmed.-visual inspection of the trimano fortis reusable leg holder, noted that the base plate was bent and one of the pins - ref-01694-01 was disassembled from the device.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user-applied excessive mechanical forces, during adjustment/connection during use.

• 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: 23679604
• Report Number: 1220246-2025-05243
• Device Sequence Number: 9661677
• Product Code: BWN
• UDI-Device Identifier: 00888867290808
• UDI-Public: 00888867290808
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown