CARROLL-GIRARD SCREW HEX-END

Additional Manufacturer Narrative

(B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED "THE SCREW FRACTURED DURING ZYGOMATIC FRACTURE REDUCTION. THE TIP OF THE REMAINED SCREW IN THE PATIENT¿S BONE WAS REMOVED USING OTHER DEVICE. THE SURGERY WAS COMPLETED USING A U TYPE HOOK AND THE DELAY WAS LESS THAN 20 MINUTES." THE FOLLOWING CONTRIBUTING FACTOR RELATED TO THE EVENT WAS REPORTED, "THE SURGEON PULLED A SCREW OBLIQUELY IN THE STRONG FORCE DURING PROCEDURE." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT WAS VISUALLY EVALUATED AND WAS SEEN TO BE FRACTURED. THERE IS NO TISSUE REMAINING IN THE THREADS. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS. THE MOST LIKELY CAUSE OF THIS IS EXCESSIVE FORCE ON AN OFF AXIS ANGLE WHILE ATTEMPTING TO APPROXIMATE TIGHTLY POSITIONED BONE FRAGMENTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE AT AN OFF AXIS ANGLE. INSTRUCTIONS FOR USE (IFU)STATES: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING WAS CORRECTED: DEVICE MANUFACTURE DATE WAS CORRECTED FROM NOV 18, 2014 TO OCT 20, 2014.