TRIMANO FORTIS REUSABLE LEG HOLDER
Received Aug 13, 2024 · Event occurred Jul 18, 2024
Report 1220246-2024-07160 · MDR key 19972996
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
TRIMANO FORTIS REUSABLE LEG HOLDERCatalog number
AR-1747-B
Lot number
68750168
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER BATCH 68750168 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, THE BASE PLATE WAS BENT CLOSED WHERE THE ATTACHMENT IS. THE RIVET WAS MISSING, MOST LIKELY BECAUSE OF THE BENT. THE MOST LIKELY CAUSE OF THIS CONDITION IS MISUSE BY THE END USER.
Description of Event or Problem
ON 07/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAD ONE OF THE SCREWS BREAK OUT DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.