DERMATOME AN HANDPIECE

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT MAKES A RATTLING SOUND DURING USE, CAUSING INACCURATE GRAFT DEPTH. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.