BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTEK HEXALOBULAR SCREWDRIVER, 21 MM

    MDR report key: 20338114 · Received September 30, 2024

    Report

    Report Number
    3008932779-2024-00003
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ZFX GMBH
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP-(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 FINDINGS BY INSPECTION OF RETURNED PART AT ZFX-INNOVATION FACILITY: A FRACTURED SCREWDRIVER ZFX02HLD21 WITHOUT LOT WAS RETURNED WITHOUT THE BROKEN TIP PORTION. THE SCREWDRIVER SHOWS AN AXIAL DEFORMATION AND A BREAKAGE. CONCLUSION: A HIGHER THAN RECOMMENDED TORQUE VALUE IN THE MOMENT OF THE SCREW FIXTURE HAS BEEN APPLIED AND/OR OFTEN USE HAVE BEEN PERFORMED. THIS CAN LED TO SUDDEN BREAKAGE. AS A POSSIBLE ROOT CAUSE AN INCORRECT HANDLING OR AS WELL AN OFTEN USAGE OF THE SCREWDRIVER MAY BE ASSUMED. NEVER THEN LESS A ROOT CAUSE CANNOT BE ESTABLISHED SECURELY BY LACK OF FURTHER INFORMATION ON THE APPLIED PROCEDURE AT THE DENTISTRY. BASED ON THE INVESTIGATED ITEMS AND AS THE ACCESSORIES USED DURING THE INTERVENTIONS ARE NOT AVAILABLE, IT IS NOT POSSIBLE TO CONFIRM THE ORIGIN OF THE INCIDENT. NO CORRECTIVE ACTION CAN BE DETERMINED. THE COMPLAINT IS CONFIRMED. THE COMPLAINT FRACTURED SCREWDRIVER IS CONFIRMED COMPLAINT CATEGORY ESTABLISHED: DENTAL: FUNCTIONAL: FRACTURE. NO SPECIFIC CAUSE FOR THE EVENT CAN BE IDENTIFIED, AS ALSO THERE ARE NO INFORMATION AVAILABLE FROM THE PERFORMED INTERVENTIONS. H3 OTHER TEXT : INVESTIGATION COMPLETED

    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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE DOCTOR REPORTED THAT THE HEXALOBULAR SCREWDRIVER FRACTURED AT THE TIP. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35267 GENTEK HEXALOBULAR SCREWDRIVER, 21 MM DENTAL DRIVER NDP ZFX GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose