FB-48-88-160P 6 STEEL WIRE 4X45CM 5.5 WRAPPED

Additional Manufacturer Narrative

STERILE SAMPLES FROM THE REPORTED LOT, INCLUDING THE ACTUAL DEVICES, WERE NOT RETURNED FOR VISUAL REVIEW OR ANALYSIS. WITHOUT THE ACTUAL REPORTED DEVICES, PHOTOS OF THE DEVICES, OR DETAILED INFORMATION ON THE METHOD USED TO REMOVE THE DEVICE FROM THE PACKAGING, PREOPERATIVE PREPARATION OF THE DEVICE, OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. NO PRODUCT INFORMATION WAS PROVIDED THEREFORE NO DEVICE HISTORY RECORD REVIEW COULD BE CONDUCTED.

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2024 THAT A NEEDLE DETACHED FROM A SUTURE INTRAOPERATIVELY TWICE. NO PATIENT INJURY OCCURRED; HOWEVER, THERE WAS A PROCEDURAL DELAY, AND INTERVENTION WAS REQUIRED TO RETRIEVE THE NEEDLES FROM THE PATIENT.