BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM, BIO-COMPOSITE- TENODESIS SCREW

    MDR report key: 16501118 · Received March 8, 2023

    Report

    Report Number
    1220246-2023-06399
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 8, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FHL TENDON TRANSFER PROCEDURE WHEREBY SURGEON INSERTED A 5.5MM BIOTENODESIS SCREW BIOCOMPOSITE INTO THE CALCANEUS AND SAID THAT THE SCREW APPEARED CRACKED ACROSS THE TOP OF THE SCREW HEAD. THE ARTHREX REFERENCE CHART WAS FOLLOWED FOR TENDON SIZE, DRILL SIZE, DEPTH, ETC. THE SURGEON COULDN¿T REMOVE THE SCREW SO LEFT IT IN TO FINISH THE SURGERY, ALTHOUGH APPRECIATING IT WAS NOT IDEAL AS APPEARED VISIBLY CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727715 5.5MM, BIO-COMPOSITE- TENODESIS SCREW SCREW, FIXATION, BONE HWC ARTHREX, INC. 5.5MM, BIO-COMPOSITE- TENODESIS SCREW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown