BABY GORILLA OLIVE WIRE, SMOOTH, 1.4MM

Additional Manufacturer Narrative

(B)(4) THIS MDR IS SUBMITTED LATE AFTER REMEDIATION EFFORTS AND A RETROSPECTIVE REVIEW OF COMPLAINT REPORTABILITY. G2: FOREIGN - EVENT OCCURRED IN ITALY. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR MEDICAL RECORDS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS LOT NUMBER WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE THE SURGEON WAS PULLING THE K-WIRE OUT, A SMALL PIECE FROM THE TIP BROKE OFF AND REMAINED FULLY EMBEDDED IN THE PATIENT'S BONE. THE PIECE WAS RETAINED WITH A DELAY OF LESS THAN 30 MINUTES AND NO PLANS HAVE BEEN MADE TO REMOVE THE FRAGMENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.