HANDPIECE, ELECTRIC DERMATOME
Received May 6, 2026 · Event occurred Oct 7, 2025
Report 0001526350-2026-00547 · MDR key 25096344
Device
Product problems
- Mechanical Problem
Patient
Not reported
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS FOUND TO HAVE LOW MOTOR SPEED DURING TESTING. THE MOTOR AND WIRING HARNESS WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE IS ATTRIBUTED TO COMPONENT FAILURE. THE EVENT WAS CONFIRMED. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE UNIT IS NOT FUNCTIONING PROPERLY. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. IT WAS FOUND DURING THE INVESTIGATION THAT THE UNIT HAS INCONSISTENT SPEED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.