BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION OFFSET ADAPTER 5 MM

    MDR report key: 6310736 · Received February 8, 2017

    Report

    Report Number
    3005180920-2017-00023
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    January 9, 2017
    Report Date
    February 8, 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

    BATCH REVIEWS PERFORMED ON 06 FEBRUARY 2017. LOT 1112575: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 JULY 2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS REPORTED ON ITEMS OF THE SAME LOT. GMK-REVISION OFFSET ADAPTER 5MM, CODE 02.07.10.9641, LOT. 1315565 (510K EXEMPT) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT. GMK-REVISION OFFSET CONNECTOR 5 MM, CODE 02.07.0005, LOT. 161800 (K102437) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2016. EXPIRATION DATE: 2021-03-30. 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. ON 07 FEBRUARY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: TWO PIECES WITH DIFFERENT LOT NUMBER HAVE BEEN ANALYZED: LOT. 112575 AND LOT. 135565. ON THE LOWER SURFACE ON BOTH DEVICES THERE ARE CLEAR SIGNS OF DAMAGE PROBABLY CAUSED BY IMPROPER USE OR IMPACTIONS. THE PIECES HAVE BEEN MEASURED AND TESTED WITH A 5MM OFFSET IMPLANT REF. 02.07.0005 WITH THE FOLLOWING RESULTS : - PIECE LOT 1112575: THE DIMENSION 15.5 +0.1+0.2 MEASURED IN CORRESPONDENCE OF THE DAMAGE AREA IS OUT OF TOLERANCE TILL 15.5135 MM. THE OUT OF TOLERANCE HAS BEEN CONFIRMED ALSO BY OUR MEASUREMENT USING A CALIPER. THE ASSEMBLING OF THE 5MM OFFSET IMPLANT REF. 02.07.0005 INTO THE OFFSET ADAPTER IS NOT POSSIBLE. - PIECE LOT 1315565: THE DIMENSION 15.5 +0.1+0.2 IS CONFORMED FOR ALL THE LENGTH OF THE SIDE, ALSO IN CORRESPONDENCE OF THE DAMAGE AREA. THE ASSEMBLING OF THE 5MM OFFSET IMPLANT REF. 02.07.0005 INTO THE OFFSET ADAPTER IS POSSIBLE: THE OFFSET ADAPTER WORKS PROPERLY. AFTER FUNCTIONAL AND DIMENSIONAL CHECK IT IS NOT CLEAR THE REASON WHY THE PROBLEM OCCURRED ALSO WITH THE SECOND PIECES LOT. 1315565 SINCE IT IS IN COMPLIANCE WITH THE SPECIFICATION. HOWEVER, ALSO THIS SECOND PIECE SHOWS SIGNS OF DAMAGE ON DIFFERENT SURFACES (NOT ONLY ON THE Ø15.5 CONNECTION AREA).

    Description of Event or Problem · 1

    THE SURGEON EXPERIENCED DIFFICULTY ASSEMBLING A 5MM OFFSET CONNECTOR DUE TO A TOLERANCE ISSUE BETWEEN THE CONNECTOR AND THE ASSEMBLY APPARATUS, USED TO DIAL IN THE APPROPRIATE ROTATION ONTO THE FEMUR. A SECONDARY APPARATUS WAS USED AND THE SAME ISSUE OCCURRED. EARLIER IN THE SURGERY THE APPARATUS PERFORMED PROPERLY WITH ANOTHER 5MM OFFSET CONNECTOR WHEN ASSEMBLING THE TIBIA. AFTER 15 MINUTE OF TRIAL AND ERROR THE SURGEON WAS ABLE TO ACHIEVE APPROPRIATE ROTATION OF THE CONNECTOR. THE SUBJECT DEVICE WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE, INSTRUMENTS WILL BE SENT BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93869 GMK-REVISION OFFSET ADAPTER 5 MM SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 1112575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other