BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE DISTAL FIBULA PLATE

    MDR report key: 7338254 · Received March 14, 2018

    Report

    Report Number
    9615128-2018-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 14, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    PMA / PMN Number
    K120409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURER'S INVESTIGATION, THE LACK OF PART OF THE TANTALUM MARKER WAS A RESULT OF A HUMAN ERROR. THE COMPANY HAS ALREADY IMPLEMENTED MEANS TO VERIFY DURING PRODUCTION PROCESS THE INTEGRITY OF THE MARKER ALONG THE PLATE. THE MINOR DAMAGE NEAR THE SCREW HOLE WAS PROBABLY CAUSED BY EXCESSIVE TORQUE APPLIED UPON SCREW TIGHTENING. AS INDICATED IN THE SYSTEM INSTRUCTIONS FOR USE, THE USER SHOULD AVOID THE APPLICATION OF HIGH TORQUE DURING SCREW TIGHTENING. IT IS NOTED THAT THE PLATE REMAINED IN SITU, WITH NO ADDITIONAL ACTIVITY REQUIRED, AND THAT THE INCIDENT IS NOT EXPECTED TO ADVERSELY AFFECT PLATE STRENGTH, AS ONLY A SUPERFICIAL LAYER WAS INVOLVED.

    Description of Event or Problem · 1

    THE TANTALUM WIRE MARKER DID NOT RUN THE ENTIRE LENGTH OF THE PLATE. IN ADDITION, WHEN THE LOCKING SCREW WAS TIGHTENED, A SUPERFICIAL SMALL FRAGMENT RAISED NEAR THE HOLE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180784 PICCOLO COMPOSITE DISTAL FIBULA PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. 91425

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR