ZIMMER AIR DERMATOME
Received Jun 25, 2026 · Event occurred Jun 23, 2026
Report 0001526350-2026-00734 · MDR key 25622239
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 - CATALOG #00880300110 WIDTHPLATE SCREWS, Z.A.D. LOT #UNK SERIAL #UNK. 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 OUTSIDE OF SURGERY DURING BIOMEDICAL ENGINEERING TEST/CHECK THE DEVICE WAS LEAKING AIR THROUGH AT INLET FITTING AND FAILING LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.