RSP 4.0MM TAPERED TIP 6BOX ST

Additional Manufacturer Narrative

(B)(4). G2: JAPAN CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PUNCH WAS NOT SHARP ENOUGH AND COULD NOT CUT A HOLE AS INTENDED DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED. A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER PROVIDED PICTURES. THE PICTURES SHOW THAT THE DEVICE HAS BEEN OPENED AND IS OUTSIDE OF THE ORIGINAL PACKAGING. THE DEVICE SHOWS SIGNS OF USE INCLUDING RESIDUE ON THE CUTTING SURFACE. NO VISIBLE DEFECTS COULD BE CONFIRMED FROM THE PROVIDED PICTURE. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.