CANNULATED SCREW SYSTEM +

Additional Manufacturer Narrative

THE EVENT WAS INVESTIGATED WITH THE INFORMATION PROVIDED. NO LOT INFORMATION WAS PROVIDED; THEREFORE A DEVICE HISTORY RECORD REVIEW FOR LOT-RELATED NONCONFORMITIES COULD NOT BE PERFORMED. AN EVALUATION COULD NOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES WERE PROVIDED THAT CONFIRMED THE EVENT OF THE SCREW HEAD BROKEN OFF OF THE SHAFT. WITHOUT FURTHER INFORMATION OR THE PHYSICAL DEVICE FOR EVALUATION, THE ROOT CAUSE CANNOT BE ESTABLISHED. FURTHER INVESTIGATIONS WILL BE PERFORMED SHOULD THE DEVICE BE MADE AVAILABLE FOR RETURN OR ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026, A 7.5 CSS+ SCREW BROKE WHEN INSERTING IT INTO THE BONE. VERY LITTLE RESISTANCE NEEDED TO BREAK THE HEAD OFF. SURGERY WAS DELAYED FOR 30 MINUTES. NO PATIENT CONSEQUENCES.