BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE FEMORAL/TIBIAL NAILING SYSTEM - DRILL BIT

    MDR report key: 7693479 · Received July 17, 2018

    Report

    Report Number
    9615128-2018-00005
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    May 2, 2018
    Report Date
    July 17, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109338699
    PMA / PMN Number
    K102369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM WAS RECEIVED AND UNDERWENT VISUAL INSPECTION. EXAMINATION OF THE PRODUCTION RECORDS OF INVOLVED DEVICE DID NOT REVEAL DEVIATION FROM ITEM SPECIFICATION.

    Description of Event or Problem · 1

    DURING OPERATION, A DRILL BIT BROKE AT THE CONNECTION AREA TO THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537470 PICCOLO COMPOSITE FEMORAL/TIBIAL NAILING SYSTEM - DRILL BIT INTRAMEDULLARY NAILING SYSTEM; DRILL BIT HSB CARBOFIX ORTHOPEDICS LTD. Drill Bit QTN04340A 07290109338699

    Patients

    Seq Age Sex Outcome Treatment
    1