HANDPIECE, ELECTRIC DERMATOME
Received May 13, 2026 · Event occurred Jul 12, 2025
Report 0001526350-2026-00567 · MDR key 25159566
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN QATAR. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS FOUND TO HAVE CORROSION ON THE MOTOR AND THE MOTOR SPEED WAS UNSTABLE. THE MOTOR WAS REPLACED AND RESOLVED THE REPORTED ISSUE. IT WAS NOTED THAT THE DEVICE WAS LAST REPAIRED IN 2021 AND HAS NOT SINCE BEEN RETURNED FOR ANNUAL PREVENTATIVE MAINTENANCE. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE HAS BEEN IDENTIFIED AS COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. 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.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THE MOTOR HAD UNSTABLE SPEED DURING DEVICE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.