TRIMANO FORTIS REUSABLE LEG HOLDER
Received May 28, 2024 · Event occurred Apr 29, 2024
Report 1220246-2024-04023 · MDR key 19404571
Device
Generic name
Operating Room Table Access
Manufacturer
Arthrex, Inc.Model number
TRIMANO FORTIS REUSABLE LEG HOLDERCatalog number
AR-1747-B
Lot number
68750169
Product problems
- Fitting Problem
- Fitting Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 4/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO FORTIS REUSABLE LEG HOLDER WAS NOT CLICKING TOGETHER WHEN TRYING TO USE DURING A CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
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.
Additional Manufacturer Narrative
COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-1747-B BATCH 68750169 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FINDS NO VISUAL ISSUES. FUNCTIONAL TESTING WAS NOT PERFORMED AS NO MATTING PART IS AVAILABLE AND THE DEVICE BATCH HAS BEEN LISTED ON A NONCONFORMANCE REPORT (NCR) AND CAPA. A SUPPLIER MANUFACTURING ISSUE IS THE CAUSE OF THE REPORTED FAILURE.