DEPUY MITEK

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE TIP OF THE REPROCESSED DEPUY MITEK'S EXPRESSEW¿ III SUTURE NEEDLE BROKE OFF INTO THE PATIENT, WHILE INSIDE THE SHOULDER CUFF. REPORTEDLY, THE SURGEON COULD NOT FIND THE TIP AND THE TIP WAS LEFT INSIDE THE PATIENT. PER REPORT, PATIENT REQUIRED ADDITIONAL ANESTHESIA MEDICATION. 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. DUE TO THE REPORTED EVENT, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. A POTENTIAL ROOT CAUSE OF THE BROKEN TIP IS DESIGN ISSUE (OF THE ORIGINAL EQUIPMENT MANUFACTURER). A DEFINITIVE ROOT CAUSE 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 DEPUY MITEK EXPRESSEW¿ III SUTURE NEEDLE DEVICE BROKE OFF INTO THE PATIENT'S SHOULDER.