BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HANDLE, ED-07827, CATALOG NUMBER: 1080-212

    MDR report key: 17754933 · Received September 15, 2023

    Report

    Report Number
    3004153240-2023-00028
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 15, 2023
    Manufacturer
    CONFORMIS INC
    Product Code
    LXH
    UDI-DI
    00810933030582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS ISSUED AUGUST 23, 2023 REGARDING AN IMPACTOR HANDLE, ED-07827. THE LOT NUMBER, VISIBLE ON THE DEVICE'S DIRECT PART MARKING, IS C201001. THIS INDICATES A MANUFACTURE DATE OF MARCH 10, 2020. THE COMPLAINT REPORTS THAT A SCREW FELL OUT OF THE IMPACTOR HANDLE, ED-07827, DURING SURGERY AND LANDED ON THE FLOOR AFTER IMPACTING THE KEEL PUNCH INTO THE TIBIA. THERE WAS NO IMPACT TO THE SURGERY AND THERE WAS NO HARM TO THE PATIENT. PICTURES WERE PROVIDED FROM THE COMPLAINANT AND THE DEVICE WAS RETURNED FOR INVESTIGATION. FROM A VISUAL ASSESSMENT OF THE DEVICE, IN ADDITION TO THE MISSING SCREW, ONE OF THE INTERNAL LOCKING ARMS WAS DISLOCATED AND NOT IN THE CORRECT POSITION (SEE INVESTIGATION PICTURE 2). VISUALLY THE SCREW THREADS HAD WEAR AND LITTLE RED LOCTITE WAS VISIBLE. UPON DISASSEMBLY OF THE DEVICE, IT WAS EVIDENT THAT THE LOCKING ARMS OF THE BUTTON MECHANISM WERE BROKEN OFF. IT CAN BE CONCLUDED THAT THE CAUSE WAS MULTIFACTORIAL. BROKEN COMPONENTS, THREAD WEAR, AND LACK OF LOCTITE CAUSED THE SCREW TO FALL OUT OF THE HANDLE. THE DESIGN HAS ALREADY BEEN CHANGED FROM A MULTI-COMPONENT BUTTON HELD IN PLACE BY FRONT FACING SCREWS TO A ONE-PIECE BUTTON HELD IN PLACE BY PINS FULLY CONTAINED WITHIN THE HANDLE. THE CHANGES WERE IMPLEMENTED ON TWO DESIGN CHANGES, DCO-011406 AND DCO-012131..

    Description of Event or Problem · 0

    THE COMPLAINT REPORTS THAT A SCREW FELL OUT OF THE IMPACTOR HANDLE, ED-07827, DURING SURGERY AND LANDED ON THE FLOOR AFTER IMPACTING THE KEEL PUNCH INTO THE TIBIA. THERE WAS NO IMPACT TO THE SURGERY AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331021 IMPACTOR HANDLE, ED-07827, CATALOG NUMBER: 1080-212 REUSABLE SURGICAL INSTRUMENT LXH CONFORMIS INC C201001 00810933030582

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown