MalfunctionGFD
DERMATOME HOSE
Received May 14, 2026 · Event occurred May 13, 2026
Report 0001526350-2026-00578 · MDR key 25173581
Device
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). D10: MEDICAL PRODUCT: ZIMMER AIR DERMATOME ITEM: #00880100100, LOT #UNK, SERIAL#(B)(6). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 BEFORE THE SURGERY THE HOSE WAS LEAKING AIR. THERE WAS NO PATIENT IMPACT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.