ZIMMER AIR DERMATOME
Received Jun 2, 2026
Report 0001526350-2026-00627 · MDR key 25361994
Device
Product problems
- Incorrect Measurement
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE CUT SKIN SCALES WERE SIGNIFICANTLY TOO THIN AND HAVE AN ALMOST SPAGHETTI-LIKE SHAPE. FURTHERMORE, THE SKIN SCALES FELL APART IMMEDIATELY, RENDERING THEM UNUSABLE FOR THEIR INTENDED PURPOSE. PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN BELGIUM. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET. ONCE THE PRODUCT IS RETURNED AND THE INVESTIGATION IS COMPLETE, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.