ABC SE;F-LOCKING CERVICAL SCREW 4.0X16MM

Additional Manufacturer Narrative

US REPORTING AGENT NOTIFIED ON (B)(4) 2015. INVESTIGATION OF THE SCREW SHOWED THE LOCKING PIN SITS ABOVE THE SCREW HEAD INSTEAD OF FLUSH WITH IT. MICROSCOPIC ANALYSIS SHOWED THE CANNULATED THREAD OF THE LOCKING PIN CONTAINS THE TIP OF AN INSTRUMENT. IT IS ASSUMED THAT THE TIP IS FROM THE RESCUE DEVICE (FJ911R). THE HEXAGON OF THE LOCKING PIN AND THE HEXAGON INSIDE THE SCREW SHOW VISIBLE DAMAGE. IT APPEARS THAT HIGH FORCES WERE APPLIED. DEVICE HISTORY AND MANUFACTURING DOCUMENTS WERE REVIEWED. ALL RECORDS COMPLY WITH SPECIFICATION AND DO NOT REPRESENT ANY DEVIATIONS. THERE ARE NO OTHER COMPLAINTS REGARDING THIS BATCH. ROOT CAUSE FOR THE FAILURE HAS BEEN DETERMINED TO BE USER RELATED. IT APPEARS THAT HIGH FORCES WERE APPLIED WITH THE SCREW DRIVER (FJ910R) AND THE RESCUE INSTRUMENT (FJ911R). THIS LED TO AN OUTWARD BENDING OF THE SCREW HEAD SEGMENTS (PETALS). WITH THE BENT PETALS, THE LOCKING PIN WAS ABLE TO BE UNLOCKED. MATERIAL OR MANUFACTURING FAILURE HAS BEEN EXCLUDED.

Description of Event or Problem

COUNTRY OF COMPLAINT: (B)(4). DURING SCREW INSERTION THE INLAY FELL OUT. THEREFORE, THE SCREW HAD TO BE EXCHANGED. THE NEW SCREW HAD TO BE FIXED WITH A BIT OF CEMENT. NO PT HARM/INJURY. OPERATION TIME DELAY ABOUT 10 MINS. OPERATION COMPLETED SUCCESSFULLY.