BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK HEXALOBULAR SCREWDRIVER, 21 MM

    MDR report key: 23263824 · Received October 10, 2025

    Report

    Report Number
    3008932779-2025-00037
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ZFX GMBH
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT: UNKNOWN / NOT PROVIDED. D4: ADDITIONAL DEVICE INFORMATION: UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE: UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. VISUAL EVALUATION: ZIMVIE RECEIVED ONE (1) ITEM ZFX02HLD21, NO LOT NUMBER COMMUNICATED. VISUAL EVALUATION WAS PERFORMED. THE SCREWDRIVER WAS WITH A BROKEN TIP. THE TIP IS NOT INCLUDED. THE REMAINED PART FROM THE SCREWDRIVER TIP HAS BEEN STRENGTHENED BY OFTEN USE AND/OR HIGH TORQUE VALUES, THE BREAKAGE AREA SHOWS SIGNES OF TORSION AND A SUDDEN BREAKAGE TYPE. 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 THAT THE TIP OF THE SCREWDRIVER FRACTURED TIGHTENING BELOW 30 NW.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350310 GENTEK HEXALOBULAR SCREWDRIVER, 21 MM DENTAL SCREWDRIVER NDP ZFX GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown