BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEVE PUSHER F/388.503 388.508 388.583

    MDR report key: 3173831 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-02510
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    February 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE ADDITIONAL EVALUATION REVEALED THE PRONGS OF THE SLEEVE PUSHER ARE BENT AND THAT AT THE USS HOOK AND SCREW HOLDER THE THREAD IS BROKEN OFF. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THESE OCCURRENCES. WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING USE CAUSED THESE DAMAGES. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF THE FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD OF THE SCREW HOLDER BROKE OFF. THERE WERE NO FRAGMENTS INSIDE THE PATIENT. THE SLEEVE PUSHERS PRONGS AT THE END WHERE THE SLEEVE SITS HAD BECOME BENT OVER TIME. THE DEVICE WAS NO LONGER PICKING UP THE NUTS FROM THE TRAY AS IT SHOULD. THIS WAS DUE TO THE THREAD INSIDE THE WRENCH BECOMING WORN OVER TIME. WITH REGARDS TO THE USS HOOK AND SCREW HOLDER THERE WAS NO INTERFERENCE WITH THE PATIENT AND THE OPERATION WAS A SUCCESS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273443 SLEEVE PUSHER F/388.503 388.508 388.583 LXH SYNTHES GMBH 3134466

    Patients

    Seq Age Sex Outcome Treatment
    1