BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM

    MDR report key: 7987523 · Received October 19, 2018

    Report

    Report Number
    2031009-2018-00047
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    July 3, 2018
    Report Date
    August 2, 2018
    Manufacturer
    TRIMED, INC
    Product Code
    HWC
    UDI-DI
    00842188103681
    PMA / PMN Number
    K093676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    TRIMED RECEIVED THE FOLLOWING REPORT ON (B)(6) 2018 FROM TRIMED SALES MEMBER LOCATED IN AUSTRALIA, REGARDING THE SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM: DURING A INTRA-OPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM (L5556) HAD THE SCREW END SNAP OFF HALFWAY THROUGH INSERTING INTO THE BONE. ALL PARTS OF THE SCREW WERE RECOVERED FROM THE PATIENT. IT WAS DETERMINED THAT THE BONE WAS QUITE SCLEROTIC COMPARED TO USUAL. THIS INCIDENT DID NOT CAUSE ANY FURTHER HARM TO THE PATIENT. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED TO TRIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828292 SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM SELF-DRILL CANNULATED COMPRESSION SCREW L THD 5.5, 56MM HWC TRIMED, INC L5556 93277 00842188103681

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown