TRIMANO FORTIS REUSABLE LEG HOLDER
Received Dec 1, 2025 · Event occurred Nov 6, 2025
Report 1220246-2025-05243 · MDR key 23679604
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
TRIMANO FORTIS REUSABLE LEG HOLDERCatalog number
AR-1747-B
Lot number
UNK
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.