BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW

    MDR report key: 7662205 · Received July 4, 2018

    Report

    Report Number
    9615128-2018-00004
    Event Type
    Malfunction
    Date Received
    July 4, 2018
    Date of Event
    June 1, 2018
    Report Date
    July 4, 2018
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109335476
    PMA / PMN Number
    K153536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO THE COMPANY THAT TAPPING WAS NOT PERFORMED PRIOR TO LAG SCREW INSERTION INTO THE BONE. AS DESCRIBED IN THE SYSTEM IFU AND SURGICAL TECHNIQUE, TAPPING SHOULD BE PERFORMED BEFORE LAG SCREW INSERTION INTO THE BONE, USING THE PROVIDED BONE TAP. IT IS NOTED THAT THE OPERATION WAS SATISFACTORILY COMPLETED. EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE DID NOT REVEAL A DEVIATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED CASE.

    Description of Event or Problem · 1

    A PICCOLO COMPOSITE PF LAG SCREW WAS DAMAGED DURING IMPLANTATION. ANOTHER SCREW WAS USED AND THE OPERATION WAS SATISFACTORILY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504158 PICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW INTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW HSB CARBOFIX ORTHOPEDICS LTD. Lag Screw PPF01268 07290109335476

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR