DERMATOME AN HANDPIECE
Received Apr 30, 2026
Report 0001526350-2026-00517 · MDR key 25041995
Device
Product problems
- Calibration Problem
- Material Deformation
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE. DURING ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE DEVICE NEEDED REPAIR FOR DAMAGED WIDTH PLATE 1,2,3,4 INCH, WORN RECIPROCATION ARM, WORN SCREW, AND CALIBRATION ERROR. THERE WAS NO PATIENT INVOLVEMENT. 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 FINLAND. 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.