QUATTRO SUTURE PASSER NEEDLE

Additional Manufacturer Narrative

(B)(4). G2; FOREIGN; JAPAN DEVICE WAS RETURNED AND IS FRACTURED, HOWEVER, IT IS UNKNOWN WHICH LOT WAS RETURNED. AS ONLY ONE DEVICE WAS CONFIRMED FRACTURED, LOT IS MARKED AS UNKNOWN WITH POSSIBLE LOTS LISTED BELOW. D4: LOT: 67071638 EXPIRATION DATE: NOVE 14, 2027 UDI: (B)(4). H4: MANUFACTURING DATE: NOV 14, 2024 D4: LOT: 67078481 EXPIRATION DATE: JAN 8, 2028 UDI:(B)(4) H4: MANUFACTURING DATE: JAN 8, 2025 VISUAL EXAMINATION OF THE RETURNED DEVICE SHOWS SIGNS OF USE AS WELL AS WEAR AND TEAR. THE TIP OF THE NEEDLE HAS FRACTURED WITH ALL PIECES BEING RETURNED. THERE WAS ALSO AN UNKNOWN SECTION OF SUTURE TAPE RETURNED WITH SEVERAL DAMAGED AREAS. MEASURED FEATURES OF THE SUTURE PASSER NEEDLE TO CONFIRM THE DEVICE IS CONFORMING TO PRINT SPECIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

IT WAS REPORTED THAT DURING THE SURGERY, THIS COMPLAINT PRODUCT COULDN'T PASS THE SUTURE NORMALLY. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.