NI

Additional Manufacturer Narrative

THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510 (K)# WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

Description of Event or Problem

ALL LOCKING SCREWS WERE TIGHTENED WITH A TORQUE LIMITER. DURING REVISION SURGERY, FOR AN UNKNOWN REASON, TWO LOCKING SCREWS BECAME JAMMED WITH THE PLATE AND WERE DIFFICULT TO REMOVE. PRESSURE WAS APPLIED TO THE SCREWDRIVER TIP, CAUSING THE SCREWDRIVER TIP TO TWIST AND DEFORMATION OF THE SCREW RECESS. THE PLATE AND SCREWS WERE REMOVED. THIS IS THE 9TH OF 9 REPORTS SUBMITTED ON THIS EVENT.