BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR HANDLE

    MDR report key: 6607694 · Received June 2, 2017

    Report

    Report Number
    3005180920-2017-00281
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 4, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 10 MAY 2017 AND INCLUDES: THE SURGERY WAS DELAY OF 5 MINUTES. BATCH REVIEW PERFORMED ON 29 MAY 2017. LOT 172382: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 MARCH 2017. EXPIRATION DATE: 2022-03-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM ON MAT16745. TO DATE, (B)(4) ITEMS OF SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE ORANGE EXTREMITY OF THE HANDLE IMPACTOR WAS BROKEN INTO THE TIBIAL WINGS IMPACTOR DURING THE SURGERY. A SECOND EFFICENCY KIT HAS BEEN OPEN IN ORDER TO COMPLETE THE KEEL INSERTION. INSTRUMENT AND PICTURE AREN'T AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388049 IMPACTOR HANDLE SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 172382

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other