ZIMMER AIR DERMATOME
Received Jun 19, 2026 · Event occurred Nov 17, 2025
Report 0001526350-2026-00694 · MDR key 25561806
Device
Product problems
- Device Reprocessing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING CLEANING THE DEVICE WENT THROUGH THE WASHER. INVESTIGATION RESULTS INDICATE THAT WIDTH PLATES WERE DAMAGED THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN, EVENT OCCURRED IN CANADA. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THAT THE DERMATOME WENT THROUGH WASHER. CONTROL BAR WAS LOOSE. WIDTH PLATES WERE DAMAGED. REPLACE WIDTH PLATES, SWIVEL, MOTOR AND ALL WORN OR DAMAGED COMPONENTS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. ABLE TO CONFIRM REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.