ZIMMER AIR DERMATOME
Received Apr 22, 2026
Report 0001526350-2026-00483 · MDR key 24954791
Device
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME IN JANUARY 2025, THE DEVICE WAS IN NEED OF REPAIR FOR AN UNKNOWN REASON. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE 4 IN. AND 1 IN. WIDTH PLATES WERE DAMAGED. THERE WAS NO PATIENT HARM/INJURY REPORTED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE SWIVEL WAS LOOSE. THE BALL BEARINGS WERE WORN. THE 4 IN. AND 1 IN. WIDTH PLATES WERE DAMAGED. THE FINE ADJUSTMENT CAMS NEEDED REPLACED. THE SWIVEL, PLANETARY CARRIER ASSEMBLY, MOTOR, FINE ADJUSTMENT CAMS, NUT BEARING LOCK, 4 IN. AND 1 IN. WIDTHPLATES WERE REPLACED. NEW VESPELS AND SEMI-CIRCLES WERE INSTALLED AND RESOLVED THE REPORTED ISSUE. IT WAS NOTED THAT THE DEVICE WAS LAST SERVICED IN 2021 AND HAS NOT SINCE BEEN RETURNED FOR ANNUAL PREVENTATIVE MAINTENANCE. 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 REPORTED EVENT WAS NOT 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.