ZIMMER AIR DERMATOME
Received Jun 16, 2026
Report 0001526350-2026-00668 · MDR key 25518617
Device
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN: CHINA. 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 DURING SURGERY THE ACTUAL DEPTH OF THE DEVICE DIFFERS SIGNIFICANTLY FROM THE SET DEPTH AND IS TOO SHALLOW. THIS WAS NOT A CALIBRATION ISSUE. THE DEVICE PROVIDED AN INCORRECT OR INACCURATE MEASUREMENT/THICKNESS. THERE WAS NO PATIENT IMPACT. THERE WAS A 5-MINUTE DELAY. THE SURGERY WAS COMPLETED AFTER PROCESSING THE ORIGINAL SKIN GRAFT. NO ADDITIONAL GRAFT WAS NEEDED. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.