VERITY HOOK, NERVE, TITANIUM HANDLE, 2 MM TIP, 7 1/4 INCH SHAFT

Additional Manufacturer Narrative

SOME PICTURES HAVE BEEN PROVIDED. PRODUCT IS BEING SENT BACK FOR EVALUATION. WE DO NOT HAVE LOT INFORMATION YET BUT SHOULD BE ABLE TO GET THAT FROM THE DEVICE ONCE IT IS RETURNED. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

COMPLAINANT ALLEGES "PART 80-1532 VERITY NERVE HOOK HAD THE BALL TIP BROKEN OFF INTO THE PATIENT. USED IN ACDF CASE. REQUIRED RETRIEVAL OF THE TIP, AND AN X-RAY TO CONFIRM ALL PIECES WERE RETRIEVED. NO HARM TO THE PATIENT."

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER OF THE DEVICE AND PICTURES OF THE PROBLEMATIC DEVICE WERE NOT PROVIDED. BASED ON THIS, WE WERE VERY LIMITED IN OUR ABILITY TO INVESTIGATE. THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.