BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK L.B.S INTRAMEDULLARY EXTENSION ROD 100MM

    MDR report key: 3939040 · Received June 27, 2014

    Report

    Report Number
    3005180920-2014-00081
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS: FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1110993-24 ITEMS PRODUCED) NO ANOMALIES WERE FOUND. CONCERNING THE INTRAMEDULLARY ROD, WE DID NOT RECEIVE THE LOT NUMBER, THUS A DOCUMENT REVIEW CANNOT BE PERFORMED. THE SURGEON WAS FINALLY ABLE TO REMOVE THE INTRAMEDULLARY ROD ONLY AND DECIDED TO LEAVE THE EXTENSION ROD INTO THE PATIENT, COMPLETING THE SURGERY. THIS IS THE SECOND CASE OF A SIMILAR ISSUE REGISTERED IN OUR DATABASE, WITH THE SAME LOT INVOLVED, REPORTED TO FDA WITH MDR 2014-00045. THE CONNECTION BETWEEN THE INTRAMEDULLARY ROD AND THE EXTENSION ROD IS REALISED BY A THREADED PART. MOST PROBABLY THE THREADED TIP OF THE EXTENSION ROD IS BROKEN INTO THE INTRAMEDULLARY ROD, DUE TO AN EXCESSIVE FORCE DURING THE INSERTION.

    Description of Event or Problem · 1

    REF # IMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378014 GMK L.B.S INTRAMEDULLARY EXTENSION ROD 100MM REUSABLE SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other