BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSUADER

    MDR report key: 3051843 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10861
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    October 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL GUIDES (388.393 AND 03.614.011) ARE RUSTING, THE TORQUE LIMITING HANDLE (30.614.035) DO NOT WORK PROPERLY, THE ROD CUTTER (03.614.021) HAS A DULL BLADE AND DOES NOT CUT WELL, THE PERSUADER (03.614.027) IS RUSTING, THE QUICK COUPLING HANDLES (324.107) ARE RUSTY, AND THE DEPTH GAUGE (03.161.028) IS BROKEN. THIS IS REPORT 3 OF 6 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 6 FOR THIS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152048 PERSUADER LXH SYNTHES GMBH 1639252

    Patients

    Seq Age Sex Outcome Treatment
    1