FIBULINK

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED ON AN UNKNOWN DATE, THAT A SURGEON WAS IMPLANTING FIBULINK FGS-1000 IN AN ORTHOPEDIC TRAUMA PROCEDURE TO REPAIR A BROKEN DISTAL FIBULA. THE SURGEON INSERTED THE FIBULINK TIBIA SCREW IN THE TIBIA AND USED THE TENSIONING CAP TO TIGHTEN THE FIBULINK SUTURE TO THE DESIRED TENSION. THE FIBULINK SUTURE BRIDGE THEN TWISTED AND BROKE. THE SURGEON THEN REMOVED THE FIBULINK TIBIA SCREW FROM THE TIBIA AND INSERTED ANOTHER NEW FIBULINK DEVICE INTO THE PATIENT. THERE WERE NO CONCERNS OR ALLEGATIONS WITH THE SECOND FIBULINK DEVICE. THERE WAS 10 MINUTES OF SURGICAL DELAY.