BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,POLYAXLOCKING,MINI T8,2.4X12MM

    MDR report key: 16774020 · Received April 19, 2023

    Report

    Report Number
    1417592-2023-00177
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    March 23, 2023
    Report Date
    May 8, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, WHEN INSERTING THE SCREW INTO THE BONE THE SURGEON NOTED "INCREASED RESISTANCE" AND THE "HEAD BROKE OFF". THE CUSTOMER REPORTED THE SCREW WAS UNABLE TO BE REMOVED AND WAS "LEFT IN THE BONE". THE CUSTOMER REPORTED THE PROCEDURE "TOOK LONGER THAN USUAL" DUE TO THE BREAKAGE BUT, "FINAL FIXATION/REPAIR WAS ACHIEVED". ACCORDING TO THE CUSTOMER THERE WAS NO SERIOUS INJURY IDENTIFIED, FOLLOW UP CARE NEEDED, OR MEDICAL INTERVENTION REQUIRED RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATING D4: LOT NUMBER 810304.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, WHEN INSERTING THE SCREW INTO THE BONE THE SURGEON NOTED "INCREASED RESISTANCE" AND THE "HEAD BROKE OFF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558722 SCREW,POLYAXLOCKING,MINI T8,2.4X12MM HWC MEDLINE INDUSTRIES, LP 810304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other