SITUATE

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: G0404-32P01C-1, GAUZE; XRAY; RFD; 4X4; 32-PLY; STRL; LF; (LOT#230604AT); 01-0043, CONSOLE; MODEL 200X (SERIAL#: (B)(6)). 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.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC RIGHT TOTAL KNEE REVISION, THE SURGEON PACKED THE BONE LUMEN WITH THE RAYTEC DEVICE. DURING THE CASE, THEY WERE MISSING A SPONGE, SO THEY SCANNED THE PATIENT AND THE SCAN WAS CLEAR. THEREFORE, THEY ASSUMED THAT THE PATIENT WAS CLEAR AND IT WAS POSSIBLY IN THE TRASH. AT THE END OF THE CASE, THEY PERFORMED AN X-RAY AND FOUND THE SPONGE IN THE BONE LUMEN. THE NEXT DAY THEY BROUGHT THE PATIENT BACK TO THE OR TO FINISH THE PROCEDURE. AFTER RETRIEVING THE SPONGE, THE POUCH WAS DAMAGED, AND THEY WERE ABLE TO PULL THE CHIP OUT THAT ALSO LOOKED TO BE DAMAGED, THE CHIP FELL OUT AND WAS NOT RESONATING WHEN SCANNED OUTSIDE THE BODY. PHOTO WAS SUBMITTED SHOWING THE CHIP OF THE DEVICE WAS BROKEN/DETACHED FROM THE SPONGE AND SPONGE FIBER COMING OFF.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE DEVICE DETECTED FALSE NEGATIVE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.