BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK HEXALOBULAR SCREWDRIVER, 21 MM

    MDR report key: 22708083 · Received August 4, 2025

    Report

    Report Number
    3008932779-2025-00024
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 28, 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).

    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 ZIMVIE RECEIVED ONE (1) ITEM ZFX02HLD21. 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 SIGNES OF TORSION AND A SUDDEN BREAKAGE TYPE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2105201524. 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 2105201524 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE RMF, 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. FOR INITIAL REPORT 3008932779-2025-00024 SUBMITTED ON 04 AUG 2025, FIELD G3 UPDATED TO 10 JUL 2025.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE SCREWDRIVER BROKE AT THE TIP DURING TIGHTENING. PROCEDURE COMPLETED.

    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
    2448782 GENTEK HEXALOBULAR SCREWDRIVER, 21 MM DENTAL DRIVER NDP ZFX GMBH 2105201524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown