UNKNOWN VARIAX 2 SCREW

Additional Manufacturer Narrative

THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE DISPOSITION IS UNKNOWN.

Description of Event or Problem

THE MANUFACTURER BECAME AWARE OF A PMCF FROM (B)(6) UNITED STATES. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE INTERNAL FIXATION OF FRACTURES IN THE RADIUS, ULNA, HUMERUS, CLAVICLE, AND DISTAL FIBULA WITH THE VARIAX 2 COMPRESSION PLATING SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿VARIAX 2 COMPRESSION PLATING¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM NOVEMBER 2015 TO NOVEMBER 2018. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAILS FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 8 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEEP INFECTION. THE REPORT STATES: ¿PATIENT 6 SUSTAINED A CLOSED BICONDYLAR TIBIA PLATEAU FRACTURE FROM A BIRD SCOOTER ACCIDENT. 41B3.2 PATTERN. A BROAD 6 HOLE STRAIGHT PLATE WAS USED ON HIS MEDIAL SIDE. NOTABLY THIS PATIENT WAS A DIABETIC, BUT NOT A SMOKER. THIS PATIENT DEVELOPED A DEEP POST OPERATIVE INFECTION VERY EARLY IN HIS CARE.¿