BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HU-FRIEDY MFG CO., LLC.

    MDR report key: 24903876 · Received April 16, 2026

    Report

    Report Number
    1416605-2026-00005
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 16, 2026
    Manufacturer
    HU-FRIEDY MFG. CO., LLC
    Product Code
    EMN
    UDI-DI
    10889950028367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BREAKAGE DUE TO CRACK IN INSTRUMENT. THE OBSERVED CUTTING-EDGE DULLING AND LACK OF TIMELY RESHARPENING MAY HAVE CONTRIBUTED TO INCREASED FORCE APPLIED DURING CLINICAL USE, FURTHER PROMOTING CRACK PROPAGATION AND EVENTUAL FRACTURE. NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECT WAS IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT INSTRUMENT BROKE AND THE PATIENT STATED THEY SWALLOWED THE TIP/PIECE. PATIENT RECEIVED AN X-RAY AND THE INSTRUMENT PIECE WAS NOT VISIBLE ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549035 HU-FRIEDY MFG CO., LLC. H6/H7 DE SCALER, EE2 #9 HANDLE EMN HU-FRIEDY MFG. CO., LLC SH6/79E2 0424 10889950028367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other