ZIMMER AIR DERMATOME
Received Jun 10, 2026 · Event occurred Sep 25, 2025
Report 0001526350-2026-00647 · MDR key 25458449
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS FOUND TO HAVE NOISY RPMS, THE CONTROL BAR WAS LOOSE AND NOT IN THE CORRECT POSITION, THE MOTOR AND SWIVEL WERE DAMAGED, THE SPRING SEAL WAS DAMAGED AND OTHER COMPONENTS WERE WORN. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. 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 OUTSIDE OF SURGERY, A CORRECTIVE REPAIR WAS NEEDED FOR A DEVICE SENT IN FOR PREVENTATIVE MAINTENANCE. DURING THE INVESTIGATION, A DAMAGED WIDTH PLATE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.