BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK HEXALOBULAR SCREWDRIVER, 28 MM

    MDR report key: 22964332 · Received September 4, 2025

    Report

    Report Number
    3008932779-2025-00033
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ZFX GMBH
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A3: GENDER: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. E1: REPORTER NAME: UNKNOWN / NOT PROVIDED. E1: EMAIL ADDRESS: UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED. ZIMVIE RECEIVED ONE (1) ITEM (B)(4), NO LOT NUMBER COMMUNICATED. VISUAL EVALUATION WAS PERFORMED. WE SEE A SCREWDRIVER WITH BROKEN TIP. THE SCREWDRIVER AND THE BROKEN TIP HAS BEEN STRENGTHENED BY OFTEN USE AND/OR HIGH TORQUE VALUES, THE BREAKAGE AREA SHOWS SIGNES OF TORSION AND A SUDDEN BREAKAGE TYPE. NO SCREW WAS SEND TO US. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS SUDDEN BREAKAGE AFTER OVERTORQING OF THE SCREWDRIVER. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED A DRIVER FRACTURED AT THE TIP. NO IMPACT ON THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082112 GENTEK HEXALOBULAR SCREWDRIVER, 28 MM DENTAL SCREWDRIVER NDP ZFX GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown