BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWER ORTHOPEDICS CORPORATION

    MDR report key: 11120286 · Received January 5, 2021

    Report

    Report Number
    3009996260-2021-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 5, 2021
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HXX
    Removal / Correction Number
    3009996260-41521-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EVENT INCLUDED A FRACTURED FLOWER SCREWDRIVER, IN WHICH THE DISTRIBUTOR CLAIMS A SMALL FRAGMENT FROM THE SCREWDRIVER WAS NOT ABLE TO BE REMOVED FROM THE PATIENT (<1MM IN SIZE). X-RAY WAS USED TO ATTEMPT TO LOCATE THIS FRAGMENT, BUT IT COULD NOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17229 FLOWER ORTHOPEDICS CORPORATION CANNULATED SCREWDRIVER (T25) HXX FLOWER ORTHOPEDICS 1902390123

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R BUPIVACAINE| DEXAMETHASONE| FENTANYL| HYDROMORPHONE| IV ANCEF 3 G| LACTATE RINGERS INFUSION| LIDOCAINE WITH EPI| MIDAZOLAM| NERVE BLOCK WITH ROPIVACAINE| ONDANSETRON| PROPHYLACTIC ANTIBIOTICS| PROPOFOL