BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

    MDR report key: 7933744 · Received October 4, 2018

    Report

    Report Number
    3005180920-2018-00748
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 4, 2018
    Manufacturer
    HPF SPA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018 MEDACTA INFORMED THE MANUFACTURER ABOUT THE EVENT. ON (B)(6) 2018 THEY REPORTED BATCH RELEASED ON DATE: 31/MARCH/2014 N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. NO SIMILAR CASES ON THIS BATCH. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS SINCE THE DRILL BIT REMAINED IN THE PATIENT. WATCHING AT THE X-RAY SENT BY THE CUSTOMER THE DRILL BIT DOES NOT LOOK DAMAGED. THE DRILL BIT DOES NOT LOOK DAMAGED. FURTHERMORE, ANALYZING THE POSITION OF THE DRILL WE CAN DEDUCED AN IMPROPER USE OF THE DEVICE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER ON 03 OCTOBER 2018 POST-REVISION X-RAY IMAGE SHOW THE PRESENCE OF A DRILL BIT IN THE FEMORAL CANAL. THIS EVENT HAS NO CLINICAL REASON. DUE TO ITS POSITION, NO CONSEQUENCE ON THE JOINT FUNCTIONALITY IS EXPECTED. NO INFORMATION CONCERNING THE LONG-TERM BEHAVIOUR OF THIS DEVICE AND ITS MATERIAL IN THE HUMAN BODY ARE KNOWN AS THE DRILL BIT IS NOT INTENDED TO BE IMPLANTED. THE SURGEON SHOULD CONSIDER AND WEIGHT RISKS AND BENEFITS OF A REOPERATION TO REMOVE THE FOREIGN BODY.

    Description of Event or Problem · 1

    THE SURGEON WAS PREPARING THE FEMUR CANAL FOR A STEM REVISION SURGERY, GIVEN THAT WAS NOT ABLE TO GO DEEPER USING STANDARD BROACHES HE TRIED TO MAKE A HOLE/GAP WITH A FLEXIBLE BAYONET DRILL BUT THE DRILL DISASSEMBLED FROM THE FLEXIBLE DRILL HOLDER AND REMAINED IN THE PATIENT. THE FLEXIBLE BAYONET SHAFT IS STILL WORKING PROPERLY, IT SEEMS NOT TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776623 VERSAFITCUP GENERAL FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56 SURGICAL INSTRUMENT FOR HIP LXH HPF SPA 14H3261

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other