BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTHREX BIO-TENDINITIS SCREW

    MDR report key: 3072827 · Received April 17, 2013

    Report

    Report Number
    MW5029859
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANTHREX
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO INSERTION, IT WAS CONFIRMED THAT THE SCREW WAS ABLE TO BE REMOVED FROM THE INSERTER, PER THE IMPLANT REP'S RECOMMENDATION. DURING INSERTION, THE INSERTER BROKE FLUSH ALONG THE SCREW. THE SCREW WAS NOTED TO BE AT AN APPROPRIATE HEIGHT AND LEVEL OF INSERTION. AN ATTEMPT WAS MADE TO REMOVE THIS BROKEN INSERTER WHICH WAS WITHIN THE SCREW, AND IT WAS ABLE TO BE PUSHED FURTHER INTO THE SCREW. WE WERE UNABLE TO REMOVE THE INSERTER WITHOUT COMPLICATIONS OF THE SCREW. THE INSERTER WAS NOT ABLE TO BE TAKEN OUT EASILY. AT THIS POINT, IT WAS FELT THAT THERE WOULD BE MORE DAMAGE TRYING TO REMOVE THE SCREW AND THE INSERTER. AGAIN, ANOTHER ARTHREX BIO-TENODESIS SCREW WAS INSERTED WHEN THE BROKE OFF IN THE SCREW/FLUSH WITH THE SCREW HEAD. INSERTER SIZE APPROX SIZE OF PENCIL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165558 ANTHREX BIO-TENDINITIS SCREW SCREW HWC ANTHREX AR-1530PS 573854

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization