BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW HA5 - LENGTH 35

    MDR report key: 6640045 · Received June 14, 2017

    Report

    Report Number
    3005180920-2017-00300
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 15, 2017
    Report Date
    June 14, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED BY MAIL OF (B)(6) ON DATE THE 30TH MAY 2017: THERE IS NO WAY TO TELL WHICH SCREWS EXACTLY WERE USED AMONG THE FOLLOWING 5 LOTS OF THE SAME REFERENCE: (B)(4). BATCH REVIEWS PERFORMED ON 12 JUNE 2017. LOT 1416012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 APRIL 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. LOT 1413504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE THIRD SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. LOT 1310157: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 MARCH 2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. LOT 106863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 OCTOBER 2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. LOT 1110551: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 OCTOBER 2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT. ON 14 JUNE 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: ON THE CUTTING BLOCK INSPECTED DURING THE VISUAL INSPECTION, THERE ARE NO SIGNS OF DAMAGE OR PRESENCE OF METAL SHAVING. ON THE HEAD OF THE FIXATION SCREWS THERE ARE EVIDENCE SIGNS OF DAMAGE CAUSED DUE TO THE CONTACT BETWEEN THE SCREW AND THE CUTTING GUIDE DURING INSERTION. IT IS CLEAR THAT THE DEBRIS COMES FROM THE FIXATION SCREWS BECAUSE OF THE LESS HARDNESS MATERIAL (AISI630) COMPARED WITH THE CUTTING BLOCK ONE (AISI420B). TO SOLVE THIS PROBLEM, WE HAVE ALREADY INTRODUCED A NEW VERSION OF FIXATION SCREWS WITH REDUCED HEAD MADE IN AISI420FMOD AND WE CHANGED THE SHAPE OF THE HOLES ON THE CUTTING BLOCK INTRODUCING CHAMFER AND RADII IN ORDER TO REDUCE THE RISK OF CONTACT BETWEEN THE SCREW AND THE GUIDE DURING FIXATION.

    Description of Event or Problem · 1

    AS THE 4-IN-1 CUTTING BLOCK WAS BEING SCREWED WITH THE HEX-DRIVER, A METAL SHAVING EMERGED AND FELL INTO THE WOUND. SHAVING WAS RETRIEVED FROM WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420493 SCREW HA5 - LENGTH 35 SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 1416012

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other