BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN2BONES

    MDR report key: 9365856 · Received November 22, 2019

    Report

    Report Number
    9365856
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    August 30, 2019
    Report Date
    October 10, 2019
    Manufacturer
    IN2BONES USA, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN2BONES CANNULATED SCREW DRIVER FROM TRAY WAS USED ON A IN2BONES SOLID SCREW. THE END OF THE SCREWDRIVER BENT WHEN THE DOCTOR WAS INSERTING THE SCREW. THE IN2BONES SCREWDRIVER WAS REMOVED FROM THE FIELD, INTACT, BUT BENT. THE SCREW DRIVER WAS RETURNED TO THE MANUFACTURER, HEALTHCARE PROVIDERS HAVE NOT RECEIVED A REPLY REGARDING THE ITEM AFTER ITS RETURN. NO HARM TO THE PATIENT, A NEW SCREWDRIVER WAS OBTAINED, LESS THEN 5 MIN DELAY, AND THE CASE CONTINUED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

    NO EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159755 IN2BONES ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH IN2BONES USA, LLC 0918-P06-24

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Unknown