BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT IMPACTION PLATE DML

    MDR report key: 6646017 · Received June 16, 2017

    Report

    Report Number
    3005180920-2017-00311
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 17, 2017
    Report Date
    July 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: THE PART WAS ANALYZED AND THE PRELIMINARY ANALYSIS IS CONFIRMED, SHOWING THE PIECE AS THE PHOTOS OF THE PRELIMINARY INSPECTION SHOWED. THIS TYPE OF DISCREPANCY WILL BE CONTINUOUSLY MONITORED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 JUNE 2017. LOT 1553836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MAY 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. ON 13 JUNE 2017 THE R&D PROJECT MANAGER PERFORMED A PRELIMINARY INVESTIGATION BASED ON THE AVAILABLE IMAGES AND COMMENTED AS FOLLOWS: IT APPEARED AS THE LOCKING DISC JUMPED OFF: THE SEPARATION OF THE LOCKING DISC PERMITTED THE PLASTIC COVERAGE TO GO AWAY FROM THE IMPACTION PLATE AND MOST COMPONENTS ARE SEPARATED FROM THE PLATE. IT IS NOT CLEAR IF A NOT REQUIRED HIGH TORQUE OF DISASSEMBLY WAS APPLIED DURING THE UNSCREWING. THIS TYPE OF DISCREPANCY WILL BE CONTINUOUSLY MONITORED. NOT YET RECEIVED.

    Description of Event or Problem · 1

    UPON REMOVAL OF THE DM CUP IMPACTOR THE WELD BROKE OFF, AND THE 2 FEET THAT CONNECT TO THE CUP BROKE OFF. THE SURGEON WAS ABLE TO RECOVER THE ALL PIECES. THIS CAUSED A 30MIN DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428015 MPACT IMPACTION PLATE DML SURGICAL INSTRUMENT FOR HIP LXH MEDACTA INTERNATIONAL SA 1553836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other