CARBON RIB-BACK BLADES SIZE 15, STERILE

Description of Event or Problem

COMPLAINANT ALLEGES "FOUND SEVERAL 15 SURGICAL BLADES WHERE THE OUTER PACKAGING IS NOT SEALED PROPERLY."

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR EVALUATION AND PICTURES WERE PROVIDED. AFTER EVALUATION, IT WAS DETERMINED THAT THE ROOT CAUSE WAS A MANUFACTURING ERROR. THE ROOT CAUSE IS MACHINE RELATED. LOSS OF REGISTRATION OCCURRED DURING THE FOIL PREPARATION, RESULTING IN THE BLADE CUTTING THE POUCH IN THE WRONG LOCATION. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.