SYMMETRY® HOOK, WEARY NERVE, BLUNT, FINE

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION, NO PICTURES WERE PROVIDED, AND LOT NUMBER WAS NOT PROVIDED DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. THE COMPLAINT COULD NOT BE CONFIRMED AND NO ROOT CAUSE WAS DETERMINED. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative

WE ARE IN PROCESS OF TRRYING TO GET THE DEVICE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. ONCE ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "RESIDENT MD NOTIFIED STAFF IN THE ROOM THAT THE TIP OF THE SURGICAL INSTRUMENT (NERVE HOOK) HE WAS USING BROKE OFF WHILE HE WAS USING IT ON THE PATIENT. BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM INSIDE THE PATIENT AND GIVEN TO RN ALONG WITH THE INSTRUMENT."