Stasys-C 3DP Cervical Standalone System

Description of Event or Problem

During an ACDF procedure, two or more pieces broke off the tip of an instrument (Cam Key) and needed to be retrieved from the patient. The user was attempting to turn a lock on the front face of an implanted cervical interbody. However, an Anchor was not fully deployed and blocked the lock from closing. The user attempted to overpower the Anchor which resulted in fracture of the instrument's tip. It was reported that, "there was no difficulty retrieving broken pieces of the instrument." It was also reported that there was no patient impact. The Anchor that was fully deployed using the system's instrumentation then the lock was closed.

Additional Manufacturer Narrative

During an ACDF procedure, two or more pieces broke off the tip of an instrument (Cam Key) and needed to be retrieved from the patient. The user was attempting to turn a lock on the front face of an implanted cervical interbody. However, an Anchor was not fully deployed and blocked the lock from closing. The user attempted to overpower the Anchor which resulted in fracture of the instrument's tip. It was reported that "There was no difficulty retrieving broken pieces of the instrument." It was also reported that there was no patient impact. The user then fully deployed the Anchors and closed the lock. The surgical technique contains clear instructions that excessive torque is not needed to close the lock. However, the user exceeded those instructions and applied excessive torque to the lock. This resulted in fracturing the tip of the Cam Key (instrument used to turn the Lock). The cause of the event was User Error.