TRIMANO FORTIS REUSABLE LEG HOLDER
Received Sep 7, 2023 · Event occurred Aug 10, 2023
Report 1220246-2023-07795 · MDR key 17697690
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
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPLAINT IS CONFIRMED. VISUAL EVALUATION NOTED THAT THE TRIMANO FORTIS REUSABLE LEG HOLDER WAS BENT. THE MOST LIKELY CAUSE OF THIS FAILURE IS APPLYING EXCESSIVE FORCE THROUGH LEVERAGING THE DEVICE.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1747-B REUSABLE LEG HOLDER WAS BENT DURING THE CASE. THE ISSUE WAS DISCOVERED AFTER THE CASE, AND THERE WAS NO PATIENT EFFECT REPORTED.