2.0X5MM HT X-DRIVE SCREW

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH A JAW DEFORMITY UNDERWENT A COMBINED IVRO AND SSRO PROCEDURE. LATER, AN X-RAY CONFIRMED THAT A SCREW ON THE IVRO SIDE LOOSEND FROM THE PLATE, AND INFECTION WAS SUSPECTED. INFECTION WAS CONFIRMED AND TREATMENT WAS STARTED. SUBSEQUENTLY, PATIENT WAS REVISED. THE SURGEON HAS DETERMINED THAT THE DISLODGED SCREW MAY HAVE HAD SOME EFFECT ON THE DEVELOPMENT OF THE INFECTION.

Additional Manufacturer Narrative

ZIMMER BIOMET (B)(4). G2: FOREIGN SOURCE: JAPAN. 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.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL 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. THIS IS A NON-STERILE PRODUCT RELATED INFECTION AND IS NOT CONSIDERED A ZB ISSUE AS IT IS LABELED AS NON-STERILE AND PRESUMED TO BE STERILIZED AND READIED ELSEWHERE; THEREFORE, PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H6, H10 AND H11.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.