BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE TIBIAL NAIL

    MDR report key: 6957302 · Received October 18, 2017

    Report

    Report Number
    9615128-2017-00047
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    August 5, 2017
    Report Date
    October 18, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K102369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RULER WAS NOT RECEIVED FOR EVALUATION. ANOTHER RADIOGRAPHIC RULER FROM DIFFERENT LOT WAS TESTED. THE SCALE AND THE LENGTH OF THE RULER WAS MEASURED AND FOUND TO BE CORRECT. IN ADDITION, THE INVOLVED TIBIAL NAIL WAS RECEIVED AND UNDERWENT AN EXAMINATION AS FOLLOWING: THE PRODUCTION RECORDS OF THE NAIL DID NOT REVEAL DEVIATION FROM SPECIFICATION. THE NAIL HAD EXTERNAL MARKS OF EXTRACTION. THE THREAD IN THE DISTAL PART OF THE NAIL WAS STRIPPED, HOWEVER THE INNER PART OF THE THREAD WAS STILL INTACT. IT SEEMS THAT EXCESSIVE FORCE WAS APPLIED ON THE NAIL DURING ITS INSERTION AND EXTRACTION FROM THE BONE. THE RULER MEASUREMENT TECHNIQUE WAS EMPHASIZE AGAIN TO THE SURGEON AS WRITTEN IN THE SURGICAL TECHNIQUE. IT WAS ALSO EMPHASIZE TO THE SURGEON, THE IMPORTANCE OF SCREWING THE REMOVAL ADAPTOR ALL THE WAY IN DURING NAIL REMOVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT GET A CLEAR MEASUREMENT FROM A RULER. THE NAIL WAS INSERTED WHICH ENDED UP BEING TOO LONG. UPON EXTRACTION, THE THREADS WERE STRIPPED USING THE REMOVAL ADAPTOR. AFTER EXTRACTING THE NAIL, A CARBOFIX CORRECT SIZE NAIL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736730 PICCOLO COMPOSITE TIBIAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. QTN04527

    Patients

    Seq Age Sex Outcome Treatment
    1