RSP 4.0MM TAPERED TIP 6BOX ST

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. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH WAS RECEIVED OPENED WITHOUT ITS ORIGINAL PACKAGING. THE PUNCH SHOWS LIGHT SIGNS OF USE WITH SOME MINOR MARKING AND SCRATCHING. THE CUSTOMER REPORTED THAT THE DEVICE DIDN'T RETURN TO THE INITIAL POSITION AT SECOND PUNCH ALTHOUGH THE FIRST PUNCH WAS SUCCEEDED. THE PUNCH PLUNGER WAS PUSHED DOWN AND THE CUTTING TIP WAS PULLED INSIDE THE BODY OF THE PUNCH. THE CUTTING TIP FULLY PULLED INSIDE OF THE PUNCH BODY AND THEN RELEASED WITHOUT ISSUE. THIS PRODUCT WAS CYCLED MULTIPLE TIMES AND WAS ABLE TO BE FULLY PULLED IN AS DESIGNED AND THEN RETURN TO ITS ORIGINAL POSITION WHEN RELEASED WITHOUT ISSUE. THE COMPLAINT IS UNABLE TO BE DUPLICATED. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE THE SURGICAL PUNCH TIP DID NOT RETURN TO THE INITIAL POSITION AFTER A SUCCESSFUL FIRST PUNCH. SUBSEQUENTLY, THE SECOND PUNCH FAILED. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED.

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). DEVICE CODE: LRY COMMON DEVICE NAME: PUNCH, SURGICAL FOREIGN SOURCE: 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.