RSP 4.5MM 6BOX ST

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. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH WAS SHOWS LIGHT SIGNS OF USE AND WAS RETURNED OUTSIDE OF ITS ORIGINAL PACKAGING. FUNCTIONAL TESTING WAS CONDUCTED BY PULLING BACK ON THE PLUNGER TO RETRACT THE CUTTING TIP. WHEN PULLED BACK THE CUTTING TIP FULLY PULLED BACK WITHIN THE PUNCH BODY. THERE WAS NO RUBBING/ BINDING OF THE CUTTING TIP. WHEN THE PLUNGER WAS RELEASED THE CUTTING TIP RETURNED TO ITS ORIGINAL POSITION AS INTENDED. 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 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

IT WAS REPORTED THAT DURING SURGERY, THE SURGICAL PUNCH DID NOT LIGATE A HOLE COMPLETELY IN THE TISSUE. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). PRIMARY CLASSIFICATION PRODUCT CODE - LRY. 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. 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.