BEUDAMED
    FDA Adverse Event Summary report: N

    GMK L.B.S. INTRAMEDULLARY ESTENSION ROD 100MM

    MDR report key: 3804304 · Received April 25, 2014

    Report

    Report Number
    3005180920-2014-00045
    Date Received
    April 25, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1110993 - 24 ITEMS PRODUCED) NO ANOMALIES WERE FOUND. NO SIMILAR PROBLEM OCCURRED ON ITEMS OF THE SAME LOT. ALSO CONCERNING THE INTRAMEDULLARY ROD, THE BATCH REVIEW DID NOT RESULT IN ANY ANOMALIES. (B)(4) ITEMS OF THE LOT 108005 HAVE BEEN PRODUCED WITHOUT ANY SIMILAR ISSUE. WE GOT THE X-RAYS WHILE WE ARE WAITING FOR THE RETURN OF THE INTRAMEDULLARY ROD. FROM THE X-RAYS ANALYSIS, IT RESULTS THAT THE FEMUR WAS QUITE CURVED AND THE SURGEON LIKELY USED A TOO LONG EXTENSION ROD. FROM THE X-RAYS ANALYSIS, IT RESULTS THAT THE FEMUR WAS QUITE CURVED AND THE SURGEON LIKELY USED A TOO LONG EXTENSION ROD. DURING THE INSERTION, PROBABLY THE SURGEON HAD TO FORCE TOO MUCH CAUSING THE DISASSEMBLING OF THE EXTENSION ROD FROM THE INTRAMEDULLARY ROD. THE SURGEON WAS FINALLY ABLE TO REMOVE THE INTRAMEDULLARY ROD ONLY AND DECIDED TO LEAVE THE EXTENSION ROD INTO THE PT, COMPLETING THE SURGERY. THIS IS THE FIRST CASE OF A SIMILAR ISSUE REGISTERED IN OUR DATABASE, REGARDLESS OF CODES AND LOTS.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250661 GMK L.B.S. INTRAMEDULLARY ESTENSION ROD 100MM REUSABLE SURGICAL INSTRUMENT FOR KNEE JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK