BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDING INSERT F/AIMING ARM F/PF

    MDR report key: 3189908 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03700
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 16, 2012
    Manufacturer
    SYNTHES, USA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AND NO CONCLUSION COULD BE DRAWN AS NO LOT NUMBER WAS PROVIDED. INVESTIGATION OF THE LOCKING SLIDING INSERT UNDER COMPLAINT REVEALED THAT IT CAN INDEED BE UNFASTENED. HENCE, ITS PROPER FUNCTION CANNOT BE GUARANTEED ANYMORE. DUE TO MISSING - INSUFFICIENT RELEASE THE NUT MIGHT INDEED COME OFF IN INDIVIDUAL CASE. THIS ISSUE HAS ALREADY BEEN RECOGNIZED, THIS IS AN OLDER VERSION AND UPDATES HAVE BEEN IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.(B)(4)

    Description of Event or Problem · 1

    THE DISC FOR FIXING THE BB SYSTEM COMES OFF VERY EASILY WHEN MANIPULATING THE IG PRIOR TO INSERTION OF DRILL BUSHING. MECHANISM JUMPS OUT OF ATTACHMENT. UNDER FORCE, THE MECHANISM JUMPS OUT OF INSERTION GUIDE ATTACHMENT. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290830 LOCKING SLIDING INSERT F/AIMING ARM F/PF LXH SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1