BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW

    MDR report key: 11997309 · Received June 15, 2021

    Report

    Report Number
    9615128-2021-00003
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 15, 2021
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109337852
    PMA / PMN Number
    K153536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE DID NOT REVEAL A DEVIATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED CASE. THE INVOLVED IMPLANT WAS NOT AVAILABLE TO THE COMPANY; THUS, ITS PHYSICAL EXAMINATION WAS NOT POSSIBLE. AN X-RAY OF THE CASE WAS PROVIDED TO THE MANUFACTURER. IT SHOULD BE NOTED, THAT THE TITANIUM SHELL IS ATTACHED TO THE LAG SCREW DURING THE MOLDING PROCESS AND THUS IN ORDER TO DISCONNECT THE TWO, HIGH TORQUE FORCES ARE REQUIRED. IN THE INVOLVED CASE, IT IS POSSIBLE THAT THE LAG SCREW WAS INSERTED TOO DEEP AND REACHED THE BONE CORTEX. THUS WHEN IT WAS UNSCREWED FOR EXTRACTION, HIGH FORCES WERE APPLIED ON THE SCREW'S THREAD LEADING TO THE SEPARATION OF THE TITANIUM SHELL.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF A PICCOLO COMPOSITE PF NAIL IN (B)(6), AFTER LAG SCREW INSERTION AND X-RAY EXAMINATION, THE SURGEON DECIDED TO REMOVE THE LAG SCREW AND REPLACE IT WITH A SHORTER LAG SCREW SINCE IT WAS TOO LONG. AFTER LAG SCREW REMOVAL, THE SURGEON DISCOVERED THAT THE TITANIUM SHELL AT THE LAG SCREW DISTAL END SEPARATED FROM THE LAG SCREW AND REMAINED IN THE BONE. A SHORTER LAG SCREW WAS INSERTED WITH SHELL REMAINING IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894860 PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. Lag Screw PPF01726 07290109337852

    Patients

    Seq Age Sex Outcome Treatment
    1