ARTHREX

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, THE TIP OF THE REPROCESSED ARTHREX SUTURELASSO¿ SD, 45 DEGREE, CURVE LEFT, W/NITINOL WIRE LOOP, (BLUE), BROKE OFF INTO THE PATIENT. IT WAS ADDED THAT ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THE INCIDENT. GENERAL ANESTHESIA WAS USED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. NO INFORMATION WAS PROVIDED WHETHER THE TIP WAS RETRIEVED FROM THE PATIENT OR WHAT MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE DEVICE TIP THAT BROKE OFF INTO THE PATIENT. THERE WAS NO SERIOUS INJURY OR ADVERSE PATIENT CONSEQUENCE REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED ISSUE OF THE DEVICE TIP BREAKING OFF INTO THE PATIENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE ISSUE WAS CONFIRMED. UPON INSPECTION OF THE RECEIVED DEVICE, IT WAS CONFIRMED THAT THE TIP HAD BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THE REPROCESSED ARTHREX SUTURELASSO¿ SD BROKE OFF INTO THE PATIENT.