AVID MEDICAL'S ORTHO LOWER EXTREMITY TRAY

Description of Event or Problem

HAIR FOUND IN BASIN. 1. WAS THE OUTER PACKAGING OR STERILITY OF THE PACKAGING COMPROMISED? NO. 2. ARE YOU AWARE OF ANY SIMILAR CLINICAL ISSUES WITH THIS PRODUCT? YES. 3. WHO WAS NOTIFIED REGARDING THIS INCIDENT? SURGERY DEPT, LOGISTICS, AND VENDOR. 4. PLEASE PROVIDE PICTURES OF THE DEFECTIVE ITEM IF POSSIBLE. SEE BELOW. 5. WAS THE MANUFACTURER/VENDOR NOTIFIED OF THIS PROBLEM? YES. 6. IF SO, BY WHOM? LOGISTICS/SURGERY. 7. IF SO, WHAT WAS THEIR RESPONSE? INVESTIGATION IS ONGOING. 8. PLEASE PROVIDE THE CASE/REF NO. FOR THE COMPLAINT THAT WAS FILED WITH THE MANUFACTURER. - HAVE NOT RECEIVED THE CASE/REF#. 9. IF NOT, PLEASE FILE A REPORT OF THE INCIDENT WITH THE MANUFACTURER AND FORWARD THE CASE/REF NO. - IT HAS BEEN FILED, CASE/REF# HAS NOT BEEN ASSIGNED. 10. PLEASE PROVIDE THE NAME AND CONTACT INFORMATION FOR THE VENDOR'S/MANUFACTURER'S POC: (B)(4), GOVERNMENT SALES MANAGER - (B)(4). 11. WAS THE PRODUCT IN QUESTION SEQUESTERED? YES. 12. WAS IT RETURNED TO THE VENDOR? YES. 13. WAS AN ADVERSE EVENT REPORTED OR FILED WITH THE FDA IN THE FORM OF A MAUDE REPORT? NO.