A&E MEDICAL / ROTATING SURGICAL PUNCHES RSP 4.0MM 6BOX ST

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H11. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PRODUCT. THE PRODUCT WAS RECEIVED OPENED. INCLUDED WITH THE RETURNED PACKAGING AND PUNCH WERE SEVERAL PIECES OF BLACK DEBRIS STORED IN A PIECE OF TAPE. ALSO INCLUDED WAS THE END CAP. THE DEBRIS WAS SENT OUT FOR FTIR ANALYSIS. THE ANALYSIS SHOWED THE DEBRIS PIECE 1 AND DEBRIS PIECE 2 SPECTRA WERE MOST CONSISTENT WITH ACRYLIC MATERIALS. THE DEBRIS PIECE 1 AND DEBRIS PIECE 2 SPECTRA SHARED SOME PEAKS WITH THE CAP SPECTRUM AND THE ATS 24-09297 UNKNOWN MATERIAL SPECTRA. THE DEBRIS PIECE 3 AND CAP SPECTRA WERE MOST CONSISTENT WITH ATS 24-09297 UNKNOWN MATERIAL AND PVC MATERIALS. FURTHER ANALYSIS WAS CONDUCTED VIA ATS#25-12943 IN ORDER TO IDENTIFY THE DEBRIS AND CAP. THE DEBRIS PIECE 1 AND DEBRIS PIECE 2 SPECTRA WERE MOST CONSISTENT WITH ACRYLIC MATERIALS. THE DEBRIS PIECE 1 AND DEBRIS PIECE 2 SPECTRA SHARED SOME PEAKS WITH THE CAP SPECTRUM AND THE ATS 24-09297 UNKNOWN MATERIAL SPECTRA. THE DEBRIS PIECE 3 AND CAP SPECTRA WERE MOST CONSISTENT WITH ATS 24-09297 UNKNOWN MATERIAL AND PVC MATERIALS. THE COMPLAINT IS CONFIRMED. HOWEVER, SINCE THE PRODUCT WAS OPENED IT CANNOT BE DETERMINED WHERE THE DEBRIS CAME FROM. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE ATTRIBUTED TO MANUFACTURING PACKAGING ISSUE. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A CARDIAC SURGERY (CABG) PROCEDURE, A SCRUB NURSE QUALITY TESTED THE ROTATING SURGICAL PUNCH DURING TABLE SETUP, AND HARD DEBRIS FELL OUT OF THE DEVICE. THIS ISSUE WAS IDENTIFIED BEFORE PATIENT USE. 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

(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.