BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION TIBIAL WEDGE SIZE 4/10MM

    MDR report key: 6198797 · Received December 22, 2016

    Report

    Report Number
    3005180920-2016-00674
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 23, 2016
    Report Date
    March 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K102437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER STATED THE PRIMARY STERILE PACKAGING WOULD HAVE BEEN AVAILABLE FOR FURTHER INVESTIGATIONS (REPORTED IN THE INITIAL REPORT, MDR 2016-00674 SENT TO FDA ON 22 DECEMBER 2016). TO DATE AND AFTER SEVERAL ATTEMPTS, MEDACTA INTERNATIONAL HAS NOT RECEIVED ANY PACKAGING RELATED TO THIS EVENT, YET. ON 22 FEBRUARY 2017 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 13 MARCH 2017 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 21 DECEMBER 2016. LOT 134636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 OCTOBER 2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION TIBIAL WEDGE SIZE 4/10MM, CODE 02.07.14TW, LOT. 102135 (K102437): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2010. EXPIRATION DATE: 2021-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PRIMARY STERILE PACKAGING FOUND BROKEN/OPENED ALONG ONE SIDE. ANOTHER ITEM, SAME REFERENCE, WAS OPENED: THE TYVEK OF INTERNAL STERILE PACKAGE WAS CUT, BUT THE TWO EXTERNAL PACKAGES WERE INTACT. THE SECOND TIBIAL WEDGE OPENED WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849602 GMK-REVISION TIBIAL WEDGE SIZE 4/10MM TIBIAL WEDGE JWH MEDACTA INTERNATIONAL SA 134636

    Patients

    Seq Age Sex Outcome Treatment
    1 Other