A&E MEDICAL / ROTATING SURGICAL PUNCHES

Additional Manufacturer Narrative

ZIMMER BIOMET (B)(4). A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH WAS RETURNED WITH ORIGINAL PACKAGING, THE PACKAGING WAS OPENED AND THE PUNCH SHOWS LIGHT SIGNS OF USE. WHEN THE PLUNGER WAS PULLED BACK ON THE PUNCH THE CUTTING TIP FULL RETRACTED INTO THE PUNCH BODY AS DESIGNED. THERE WERE NO SIGNS OF BINDING OR MANUFACTURING DEFECTS. WHEN THE PLUNGER WAS RELEASED THE PUNCH RETURNED TO ITS ORIGINAL POSITION AS DESIGNED. THE COMPLAINT CANNOT BE RECREATED. 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. THIS EVENT WAS PREVIOUSLY REPORTED ON MFR NUMBER 0001032347-2023-00143.

Description of Event or Problem

IT WAS REPORTED BY THE REP THAT THE PUNCH DID NOT MAKE A CLEAN CUT AND THE SURGEON HAD TO DO ADDITIONAL SUTURING TO THE SITE. DELAY IS THOUGHT TO BE 2 TO 3 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.