BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPAR DISTRACTION PIN SCREWDRIVER

    MDR report key: 8671890 · Received June 5, 2019

    Report

    Report Number
    9610612-2019-00355
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    June 11, 2018
    Report Date
    June 5, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INSTRUMENT BROKE INTRAOPERATIVELY. DURING A SURGICAL PROCEDURE IT WAS REPORTED THAT THERE WAS A BREAK IN THE SCREWDRIVER HEAD WHEN SCREWING A CERVICAL SCREW (ORTHOGENESIS) RESULTING IN WOOD SHAVINGS FROM THE WOODEN HANDLE TO FALL INTO THE WOUND. THE SURGEON PERFORMED REPEATED RINSING OF THE SURGICAL WOUND. THE DEVICE WAS REMOVED FROM THE STERILE FIELD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466045 CASPAR DISTRACTION PIN SCREWDRIVER INSTRUMENTS CERVICAL STABILISA HXX AESCULAP AG FF906R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention