HANDPIECE, ELECTRIC DERMATOME
Received May 14, 2026
Report 0001526350-2026-00581 · MDR key 25178532
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE MOTOR SPEEDS WERE NOT STABLE, THE CABLE WAS DAMAGED (NO EXPOSED METAL WIRING), AND THE DEVICE WAS OUT OF CALIBRATION. THE MOTOR AND PLUG HARNESS WERE REPLACED, AND THE DEVICE WAS RECALIBRATED TO RESOLVE THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO COMPONENT FAILURE AS THE DEVICE EXHIBITS WEAR AND TEAR FROM REPEATED USE. THE EVENT IS CONFIRMED. 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 TRENDS. G2: FOREIGN - EVENT OCCURRED IN NETHERLANDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING PM, THE UNIT HAD AN UNKNOWN FAUL FAULT. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.