BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAFITCUP DM LINER INSERTER

    MDR report key: 2111908 · Received May 24, 2011

    Report

    Report Number
    3005180920-2011-00031
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    Removal / Correction Number
    047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RUSTY PIECE RETURNED BACK TO THE MANUFACTURER ON THE (B)(4) 2011: THEN, WE SENT IT FOR ANALYSIS TO OUR SUB-SUPPLIER THAT MANUFACTURED IT FOR US. THEY REFERRED TO THEIR RAW MATERIAL SUPPLIER AND, ON THE (B)(4) 2011, THEY FINALLY DISCOVERED THAT A WRONG MATERIAL WAS USED: (B)(4). FOR A MISTAKE, THIS RAW MATERIAL WAS SHIPPED TO OUR SUPPLIER WITH A WRONG CERTIFICATE IN WHICH WAS DECLARED THE RIGHT MATERIAL TO BE USED: THIS IS WHY OUR SUPPLIER HAS NOT REALIZED THAT A WRONG MATERIAL WAS RECEIVED AND THEY USED IT ONLY TO PRODUCE THE BASES OF THE INSERTER (B)(4). FOR THIS REASON, ON THE 20TH OF MAY, MEDACTA INTERNATIONAL HAS SENT A CIRCULAR LETTER TO ALL THE CUSTOMERS THAT HAVE THIS LOT TO RECALL BACK THESE PIECES. THE RISK FOR THE PATIENTS IS JUDGED LOW, AS A RUSTY PIECE IS EASILY DETECTABLE BEFORE THE SURGERY.

    Description of Event or Problem · 1

    THE BOTTOM OF THE DM LINER INSERTER HAS RUSTED OUT. THE EVENT WAS DETECTED DURING THE STERILIZATION PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP DM LINER INSERTER REUSABLE SURGICAL INSTRUMENT FOR HIP. MEH MEDACTA INTERNATIONAL SA 105549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK