BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,NON-LOCKING,MINI T8,2.7 X 16MM

    MDR report key: 16774035 · Received April 20, 2023

    Report

    Report Number
    1417592-2023-00178
    Event Type
    Injury
    Date Received
    April 20, 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 REMOVED WITH A "SCREW REMOVAL SET" AND AN ADDITIONAL SCREW WAS INSERTED. 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
    1559702 SCREW,NON-LOCKING,MINI T8,2.7 X 16MM HWC MEDLINE INDUSTRIES, LP 810304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other