DIVERGENCE MINI-PLATE SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING SURGERY SET-UP, THE DEVICE WAS FOUND WITH THE PROTECTIVE SHEATH DETACHED FROM THE BASE. THE ITEM WAS REMOVED FROM THE STERILE SET-UP AND SET ASIDE. THERE WAS NO PATIENT CONTACT, AND THE PATIENT REMAINED ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE WITHOUT ANY ISSUES.

Additional Manufacturer Narrative

G2: COUNTRY OF EVENT IS CANADA. H3: PRODUCT ANALYSIS OF PART# 6630908, LOT# EM15L037 VISUAL AND OPTICAL INSPECTION CONFIRMED THE AWL HAS BROKEN AT THE LASER WELD. THE DAMAGE TO THE INSTRUMENT IS CONSISTENT WITH OVERLOAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.