ELEVATOR #301
Received Jan 29, 2026 · Event occurred Jan 2, 2026
Report 0001032347-2026-00021 · MDR key 24206736
Device
Generic name
Elevator, Surgical, Dental
Manufacturer
Biomet MicrofixationCatalog number
09-0257
Lot number
F18
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE INSTRUMENT TIP FRACTURED DURING THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND THE PROCEDURE WAS NOT DELAYED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H2; H3; H6; H11. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED ELEVATOR. THE ELEVATOR SHOWS SIGNS OF MULTIPLE USES INCLUDING HEAVY MARKING AND SCRATCHING ON THE ELEVATOR SURFACE. FURTHER INSPECTION SHOWED THE ELEVATOR TIP HAS FRACTURED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.