PF SET SCREW, STANDARD, L=120MM, PPS

Additional Manufacturer Narrative

WE HAVE INSPECTED THE DHF OF THE AFFECTED NAIL AND SET SCREW AND THE MATERIAL CERTIFICATE AND THE BATCH WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE'S 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. THE FRACTURE HAS NOT HEALED AND THE PATIENT EXPERIENCED A FALL ON HIS LEFT (IMPLANTED) SIDE. 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 REPORT INCLUDES 1 NAIL AND 1 SET SCREW AND THEREFORE THIS IS REPORT 2/2.

Description of Event or Problem

IT WAS REPORTED THAT A PF NAIL AND A SET SCREW BROKE APPROX. 15 MONTHS POST-OP DUE TO A PATIENT FALL.