TARGET XL 360 SOFT 6MM X 20CM

Additional Manufacturer Narrative

DUE TO AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) HAS CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE VISUAL/MICROSCOPIC INSPECTION WAS PERFORMED AS THE SUBJECT MAIN COIL WAS SEEN TO BE STRETCHED, FRACTURED AND THE SUTURE DAMAGED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE REPORTED EVENT WAS CONFIRMED BASED ON ANALYSIS. THE SUBJECT DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER THAT THE COIL (SUBJECT DEVICE) ¿SHREDDING¿ DURING A PROCEDURE. DURING ANALYSIS, THE SUBJECT MAIL COIL WAS SEEN TO BE FRACTURED, THE SUTURE DAMAGED AND THE MAIN COIL TO BE SEVERELY STRETCHED. IT IS PROBABLE THERE WAS A LOT OF PULLING OR FRICTION DURING THE PROCEDURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿MAIN COIL STRETCHED¿ AS THESE DEFECTS APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS ASSIGNABLE CAUSE ¿MAIN COIL STRETCHED¿, ¿MAIN COIL BROKEN/FRACTURED DURING USE¿ AND ¿MAIN COIL SUTURE DAMAGED¿ AS THESE DEFECTS APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL FACTORS DURING USE.

Description of Event or Problem

THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.