QUATTRO SUTURE PASSER NEEDLE

Additional Manufacturer Narrative

(B)(4) G2: FOREIGN - EVENT OCCURRED IN BRAZIL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A SURGICAL NEEDLE BROKE INTRA-OPERATIVELY WHEN ACTIVATED WITHIN A TIGHT JOINT. THE DEVICE FRACTURED DURING ACTIVATION, AND ANOTHER STERILE NEEDLE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.