TRIMANO FORTIS REUSABLE LEG HOLDER

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 04/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER HAD A SCREW POP LOOSE AND CAUSED IT TO WOBBLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

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.