CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MM

Additional Manufacturer Narrative

WE HAVE INSPECTED THE DHF OF THE AFFECTED SCREWS AND THE MATERIAL CERTIFICATE AND THE BATCH WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE ARTICLE MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED FOLLOWING A TECHNICAL INVESTIGATION OF THE DEVICE AND A CLINICAL FOLLOW-UP WITH THE OPERATING SURGEON REGARDING THE CIRCUMSTANCES OF THE EVENT. BASED ON THE INFORMATION AVAILABLE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, I.T.S. GMBH OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS IS REPORT 1 OF 2.

Description of Event or Problem

IT WAS REPORTED THAT THE DISTAL THREAD END OF TWO CANNULATED SCREWS HAD STRIPPED DURING INSERTION.