ZIMMER AIR DERMATOME

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE UNIT WAS CUTTING TOO DEEP. NO INFORMATION ON PATIENT IMPACT PROVIDED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION OR PRODUCT IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

Additional Manufacturer Narrative

THIS INCIDENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. (B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.