BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER, 2.5MM

    MDR report key: 4602626 · Received March 9, 2015

    Report

    Report Number
    3004608878-2015-00084
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Report Date
    February 11, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RETURNED. THE DEVICE EVALUATION IS IN PROGRESS. THE RESULT OF THE DEVICE EVALUATION WILL BE REPORTED IN A FOLLOW-UP MDR SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE RECENTLY RECEIVED BY THE ODC DECONTAMINATION TEAM. BOTH HEX DRIVERS WERE DAMAGED AT THE TIP. THE DEFECTIVE DRIVERS WERE DETECTED BY THE ODC DECONTAMINATION TECHNICIAN. IT WAS REPORTED THE SURGERY WENT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160487 HEX DRIVER, 2.5MM NA HXX INTEGRA LIFESCIENCES CORPORATION OH/USA 2735670001

    Patients

    Seq Age Sex Outcome Treatment
    1