ZIMMER AIR DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, THE UNIT STOPPED WORKING DURING OPERATION, AND THE SKIN GRAFT BECAME TRAPPED IN THE DERMATOME AND COULD NO LONGER BE USED. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS, AND THERE¿S NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN - EVENT OCCURRED IN SWEDEN.