MalfunctionGFD
UNKNOWN HOSE
Received Jul 1, 2026
Report 0001526350-2026-00766 · MDR key 25682460
Device
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). D10: ITEM#: 88710100, DERMATOME AN HANDPIECE, SERIAL#: (B)(6). 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 OUTSIDE OF SURGERY THE HOSE WAS TAGGED FROM THE OPERATING ROOM, STATING THAT IT WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.