4.0 X 14 CANCELL. SCREW

Description of Event or Problem

IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE SYMPTOMS SUBSEQUENTLY RESOLVED AND THE DEVICE REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). D10: ONE-THIRD TUBULAR PLT 4 HOLE CAT#: 47493500403 LOT#: 64980726. ONE-THIRD TUBULAR PLT 10 HOLE CAT#: 47493501003 LOT#: 65039919. 4.0 X 40 PART THD CANC SCR CAT#: 47484004001 LOT#: 64768001. 4.0 X 35 PART THD CANC SCR CAT#: 47484003501 LOT#: 63635448. 3.5MM CORT. SCREW 16MM LNG S CAT#: 47483501601 LOT#: 65960879. 3.5MM CORT. SCREW 16MM LNG S CAT#: 47483501601 LOT#: 65960879. 3.5MM CORT. SCREW 16MM LNG S CAT#: 47483501601 LOT#: 65960879. 3.5MM CORT. SCREW 16MM LNG S CAT#: 47483501601 LOT#: 65960879. 3.5MM CORT. SCREW 16MM LNG S CAT#: 47483501601 LOT#: 65601975. 3.5MM CORT. SCREW 14MM LNG S CAT#: 47483501401 LOT#: 65514783. 3.5MM CORT. SCREW 20MM LNG S CAT#: 47483502001 LOT#: 64939904. 3.5MM CORT. SCREW 18MM LNG S CAT#: 47483501801 LOT#: 65901451. 3.5MM CORT. SCREW 24MM LNG S CAT#: 47483502401 LOT#: 65271221. 3.5MM CORT. SCREW 28MM LNG S CAT#: 47483502801 LOT#: 64913111. G2: UNITED KINGDOM. THE COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.