BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK HEXALOBULAR SCREWDRIVER, 28 MM

    MDR report key: 22963195 · Received September 4, 2025

    Report

    Report Number
    3008932779-2025-00032
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 20, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED. ZIMVIE RECEIVED ONE (1) ITEM ZFX02HLD28. VISUAL EVALUATION WAS PERFORMED. WE SEE A SCREWDRIVER WITH BROKEN TIP. THE SCREWDRIVER HAS DAMAGES AND SCRATCHES FROM USE. THE SCREWDRIVER TIP HAS BEEN STRENGTHENED BY OFTEN USE AND/OR HIGH TORQUE VALUES, THE BREAKAGE AREA SHOWS SIGNS OF TORSION AND A SUDDEN BREAKAGE TYPE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 24110080844. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 24110080844 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE¿. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS SUDDEN BREAKAGE AFTER OVERTORQUING 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

    THE DOCTOR REPORTS THAT THE 28 MM LONG HEX SCREWDRIVER BROKE AT THE TIP WHILE SCREWING IN AN ANGLED CHANNEL TIBASE. PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233816 GENTEK HEXALOBULAR SCREWDRIVER, 28 MM DENTAL SCREWDRIVER NDP ZFX GMBH 2110080844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown