TRIMANO FORTIS REUSABLE LEG HOLDER
Received Dec 12, 2024 · Event occurred Nov 20, 2024
Report 1220246-2024-08797 · MDR key 20914045
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
TRIMANO FORTIS REUSABLE LEG HOLDERCatalog number
AR-1747-B
Lot number
38197077
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAS RIBS THAT ARE COMING OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.