MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jun 22, 2026
Report 0001526350-2026-00705 · MDR key 25577204
Device
Product problems
- Loose or Intermittent Connection
- Mechanical Problem
- Calibration Problem
- Material Deformation
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS INCIDENT IS BEING RECORDED UNDER (B)(4). G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. E1: TELEPHONE: (B)(6). THE DEVICE WILL BE RETURNED FOR ANALYSIS, 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 THE UNIT WAS SENT IN FOR PM AND NOTED TO NEED REPAIR FOR WORN RECIPROCATION ARM LOOSE SWIVEL, MOTOR ISSUE, DAMAGED WIDTH PLATE, AND CALIBRATION ERROR. NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.