BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GO-EZ

    MDR report key: 5857571 · Received August 9, 2016

    Report

    Report Number
    1832656-2016-00001
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 14, 2016
    Report Date
    August 9, 2016
    Manufacturer
    BIOPRO, INC
    Product Code
    HWC
    PMA / PMN Number
    K081149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE RETURNED COMPONENT COMPARED TO THE 10 PIECES THAT WERE TESTED TO FAILURE INDICATES THAT THE PIECE THAT BROKE DURING SURGERY WAS DRIVEN OVER A BENT GUIDE WIRE WHICH IS SPECIFICALLY CAUTIONED AGAINST IN THE SURGICAL PROCEDURE. THIS WAS NOT THE SURGEONS FIRST TIME UTILIZING THIS PRODUCT AND AN IN-SERVICE HAD BEEN CONDUCTED FOR THE DOCTOR AND THE STAFF IN THE PAST.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED THE SALES REP AND INDICATED THAT A 3.0X24MM GO-EZ SCREW BROKE DURING SURGERY AND THE COUNTERSINK THEY HAD WAS DULL. THE PARTS WERE RETURNED TO BIOPRO FOR EVALUATION. THE HEAD OF THE SCREW HAD COME OFF WHILE THE SCREW WAS BEING INSERTED INTO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514799 GO-EZ BONE SCREW HWC BIOPRO, INC 18194 116545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other