VERITY HOOK, NERVE, 2.0 MM BLUNT TIP

Description of Event or Problem

COMPLAINANT ALLEGES "THE HOOK, VERITY, NERVE, TI HANDLE, 2.0 MM BLUNT TIP, SS SHAFT, 7 1/4 IN, PART # 80-1532 MADE BY ASPEN SURGICAL BROKE OFF IN THE PATIENT DURING SPINAL SURGERY. THE PIECE WAS RETRIEVED, SO THERE WAS NO PATIENT HARM, JUST A PRODUCT DEFECT."

Additional Manufacturer Narrative

THE ONLY INFORMATION THAT WE RECEIVED FOR THIS INCIDENT WERE INCLUDED ON MW5160111. THE REPORTER WAS CONFIDENTIAL, SO WE ARE UNABLE TO CONTACT THEM TO ASK FOR THE DEVICE TO BE RETURNED, OBTAIN PICTURES, OR GET ADDITIONAL INFORMATION. BASED ON WHAT WAS REPORTED, THE INVESTIGATION WAS VERY LIMITED AND A ROOT CAUSE CANNOT BE ESTABLISHED. THIS SHOULD BE CONSIDERED THE FINAL REPORT, HOWEVER IF ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.