ARTHREX

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE REPROCESSED ARTHREX SUTURELASSO SD, 90 DEGREES UP (BLACK) 1.8MM, BROKE OFF INTO PATIENT. THE TIP OF THE DEVICE WAS REPORTEDLY RETRIEVED FROM THE SURGICAL SITE THROUGH AN UNKNOWN METHOD. THERE WAS NO REPORT OF A SERIOUS INJURY, AN ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THE INCIDENT. DUE TO THE REPORTED DEVICE FAILURE AND THE REQUIRED INTERVENTION TO RETRIEVE THE DEVICE TIP THAT BROKE OFF INTO PATIENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS PERFORMED AND THIS 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 RELEVANT 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 PATIENT.