BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3072511 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10343
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES MNI. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATED: MINOR SCRATCHES AND NICKS ON THE EDGES AND THEY ARE NOT MANUFACTURE RELATED. BECAUSE ALL RELEVANT FEATURES CONFORM TO PRODUCT SPECIFICATIONS, THIS COMPLAINT IS INVALID.

    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. ADDITIONAL INFORMATION: THE PRODUCT DEVELOPMENT EVENT EVALUATION REPORTED THAT THE COLLAR IS APPROPRIATE FOR ITS INTENDED USE. THE DESIGN IS CONSISTENT WITH ITS INTENDED USE AND THE COMPLAINT DESCRIPTION DOES NOT APPEAR TO BE RELATED TO THE PRODUCT DESIGN. A COMPLETE INVESTIGATION OF THE COMPLAINT DESCRIPTION ABOVE HAS BEEN CONDUCTED ON PREVIOUS COMPLAINTS AND THE OVERALL ANALYSIS OF THE INVESTIGATION INDICATED THAT NO ROOT CAUSE COULD BE FOUND FOR THE REPORTED COMPLAINT. SEVERAL PROCESS IMPROVEMENTS HAVE BEEN IDENTIFIED AND IMPLEMENTED. INCORRECT 510K CHOSEN ON INITIAL SHOULD BE K091689. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING L2-ILIUM FUSION PROCEDURE, AS THE SURGEON WAS TORQUING THE NUTS FOR THE FINAL TIGHTENING, 3 OF THE COLLARS BROKE AND ALL PIECES WERE RETRIEVED BY THE SURGEON. THIS HAPPENED ON 3 OF THE 12 NUTS AND COLLARS BEING USED IN THE CONSTRUCT. THE SURGEON THEN SELECTED 3 MORE COLLARS AND NUTS AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. EVENT #3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175411 TI NUT 11MM WIDTH ACROSS FLATS MNH SYNTHES BRANDYWINE 6929700

    Patients

    Seq Age Sex Outcome Treatment
    1