TRIMANO FORTIS REUSABLE LEG HOLDER
Received Feb 12, 2024 · Event occurred Jan 23, 2024
Report 1220246-2024-00914 · MDR key 18688607
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
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 01/23/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1747-B TRIMANO KNEE HOLDER WOULD NOT CLICK IN AND WOULD GET STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. 10 MINUTE DELAY IN CASE. CASE COMPLETED WITH NO 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
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX CONCLUDED THAT THE MOST LIKELY CAUSE. THE CAUSE OF THE REPORTED FAILURE IS SUPPLIER MANUFACTURING PROCESS ISSUE. ADDRESSED ON NCR-25134 AND CAPA-00506. THE COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURES, WHICH DISPLAY THE DEVICE BATCH IDENTIFIER IN THE NON-CONFORMANCE RESULTS INVESTIGATIONS.