ZIMMER SKIN GRAFT MESHER

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE GUIDANCE PLATE/CARRIER GUIDE WAS BENT AND NEEDS STRAIGHTENING. WHILE ROLLING THE PLATE, THE TISSUE TORE. THERE WAS AN UNKNOWN IMPACT TO THE PATIENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.