ZIMMER AIR DERMATOME
Received Jul 1, 2026
Report 0001526350-2026-00755 · MDR key 25677230
Device
Product problems
- Degraded
- Unstable
- Calibration Problem
- Noise, Audible
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS NOISY, THE DEVICE WAS DEGRADED INSIDE. NEED TO REPLACE SWIVEL MOTOR AND ALL WORN OR DAMAGED COMPONENTS. RPM WERE IN SPECIFICATION, CONTROL BAR POSITION PASSED ALL TEST. ALL CALIBRATION READINGS WERE OUT OF SPECIFICATION, EXPECT FOR READING 30 THAT WAS IN SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.