BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE DISTAL FEMUR PLATE

    MDR report key: 6833779 · Received August 31, 2017

    Report

    Report Number
    9615128-2017-00013
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    December 21, 2016
    Report Date
    March 23, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HRS
    UDI-DI
    07290109335230
    PMA / PMN Number
    K143496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURER INVESTIGATION, THE DIFFICULT PLATE-HANDLE CONNECTION WAS THE RESULT OF MINOR OFFSET IN THE LOCATION OF PLATE RECESS INTENDED TO CONNECT THE PLATE TO THE INSERTION HANDLE. IT IS NOTED, THAT ALTHOUGH DIFFICULT, CONNECTION WAS POSSIBLE; THE PLATE WAS SATISFACTORILY IMPLANTED. IT WAS CONCLUDED THAT THE REPORTED CASE WAS A RESULT OF A MANUFACTURING FAULT. THIS REPORT IS SUBMITTED FOLLOWING AN FDA INSPECTION AT THE MANUFACTURER FACILITY. DEVICE IS STILL IMPLANTED.

    Description of Event or Problem · 1

    DURING OPERATION, IT WAS DIFFICULT TO CONNECT A PICCOLO COMPOSITE DISTAL FEMUR PLATE AND ITS HANDLE (OUTSIDE THE PATIENT BODY). NEVERTHELESS, THE PHYSICIAN SUCCEEDED TO CONNECT THE INSERTION HANDLE TO THE PLATE, AND THE PLATE WAS SATISFACTORILY IMPLANTED. IT WAS NOTED THAT THE TANTALUM WIRE DID NOT EXTEND THROUGH THE ENTIRE PLATE PERIMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615072 PICCOLO COMPOSITE DISTAL FEMUR PLATE BONE PLATE HRS CARBOFIX ORTHOPEDICS LTD. Distal Femur Plate 90848 07290109335230

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR