A&E MEDICAL / ROTATING SURGICAL PUNCHES 4.0MM

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE REPORTED EVENT IS CONFIRMED BASED ON THE PROVIDED PHOTOS. NO PRODUCT WAS RETURNED. A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER-PROVIDED PICTURES. THE PICTURES SHOW THAT THE PACKAGE HAS BEEN OPENED AND PLACED INTO A SECONDARY BAG. A SMALL PIECE OF BLACK CAN BE SEEN INSIDE THE PACKAGE. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN: THE EVENT OCCURRED IN CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CARDIAC SURGERY (CABG) PROCEDURE, THE SCRUB NURSE TESTED A ROTATING SURGICAL PUNCH WITH A FLAT TIP ON A STERILE TOWEL DURING TABLE SETUP, AT WHICH POINT A BLACK PIECE OF PLASTIC FELL FROM THE END OF THE DEVICE. THIS ISSUE WAS IDENTIFIED BEFORE PATIENT USE, PREVENTING THE PLASTIC FROM POTENTIALLY ENTERING THE AORTA. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H11. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PRODUCT. THE PACKAGE HAS BEEN OPENED AND THE OPENED PACKAGE HAS BEEN PLACED INTO A SECONDARY BAG. A SMALL PIECE OF BLACK CAN BE SEEN INSIDE OF THE PACKAGE. THE PRODUCT WAS RETURNED FOR FTIR ANALYSIS. THE SPECTRUM PRODUCED FROM THE UNKNOWN MATERIAL WAS CONSISTENT WITH POLYURETHANE. THE REPORTED EVENT IS CONFIRMED, BASED ON RETURNED PRODUCT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: B5, G3, H1, H2, H3, H6 AND H11. ROOT CAUSE IS ATTRIBUTED TO MANUFACTURING PACKAGING ISSUE. A CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE REPORTED MALFUNCTION. IF ANY FURTHER INFORMATION IS FOUND 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

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