BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK¿ HEXALOBULAR SCREWDRIVER, 21 MM

    MDR report key: 24019180 · Received January 9, 2026

    Report

    Report Number
    0001038806-2026-00160
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    October 25, 2025
    Report Date
    March 24, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NDP
    UDI-DI
    04251881700428
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. H11: ADDITIONAL NARRATIVE. ZIMVIE DID NOT RECEIVE ONE (1) ITEM GENTEK HEXALOBULAR SCREWDRIVER, 21 MM FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, AND RISK MANAGEMENT FILE (RMF). COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 2110201830 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿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. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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

    DOCTOR REPORTED THAT WHILE DELIVERED SCREW RETAINED IMPLANT CROWN, USING ZIMVIE STANDARD BASE, THE PROSTHETIC SCREW WAS TIGHTENED INADVERTENTLY MORE FREE HAND 30 NCW. WHEN TRYING TO RELEASE THE SCREW TO TIGHTEN CORRECTLY THE HEAD OF THE DRIVER WAS FRACTURED.

    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
    198953 GENTEK¿ HEXALOBULAR SCREWDRIVER, 21 MM DENTAL SCREWDRIVER NDP ZIMVIE US CORP LLC 2110201830 04251881700428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown