HANDPIECE, ELECTRIC DERMATOME
Received Jul 9, 2026 · Event occurred Dec 22, 2025
Report 0001526350-2026-00808 · MDR key 25768152
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT REQUIRES A FULL SYSTEM CHECK. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DURING THE INVESTIGATION, IT WAS FOUND THAT THE DEVICE HAD ERRATIC MOTOR SPEEDS. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
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 ERRATIC, THE LEVER WAS DAMAGED AND STUCK, AND THE CONTROL BAR WAS LOOSE. THE BALL PLUNGER, LEVER, BEARINGS, EXTERNAL E-RING, RETAINING RING, SPRING SEAL, SCREWS, INSULATOR, ECCENTRIC SHAFT, SWITCH MOUNT, MOTOR, POWER SWITCH, END CAP, PLUG HARNESS, O-RING, COMPRESSION CAP, AND WASHERS WERE REPLACED, AND THE CONTROL BAR WAS ADJUSTED 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 WAS 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 FOR TRENDS.