BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    MDR report key: 3021717 · Received March 26, 2013

    Report

    Report Number
    2530088-2013-10269
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. AFTER REVIEWING THE DHR FOR ALL MATERIAL COMPONENTS AND ASSEMBLIES, NO DISCREPANCIES WERE FOUND THAT COULD BE RELATED TO THE COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THE COLLET IS NOT POPPED UP AS NOTED BUT IS ROTATED APPROXIMATELY 30 DEGREES TO THE ITS PROPER POSITION SUCH THAT A ROD CANNOT BE FULLY SEATED INTO IT. THERE ARE MARKS IN THE STARDRIVE RECESS AND THE INTERNAL THREADS IN THE SCREW HEAD THAT INDICATE THE HOLDING SLEEVE AND SCREWDRIVER WERE INSERTED INTO THE SCREW DURING THE PROCEDURE. THE POSITIONING TOOL ALSO MAINTAINS ALIGNMENT OF THE COLLET RELATIVE TO THE BODY. THE DESIGN IS FOR THE SLOTS TO ALIGN AND A TOOL IS PROVIDED TO ENSURE ALIGNMENT. THEREFORE, THIS COMPLAINT IS INVALID WITH RESPECT TO THE DESIGN AND MANUFACTURING.

    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. THIS IS REPORT 2 OF 2 FOR (B)(4). ORIGINAL AWARENESS DATE IS 01/05/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE INSIDE THE SCREW HEAD OF THE SCREW POPPED UP. SURGEON BACKED OUT THE SCREW BECAUSE HE COULD NOT SEAT THE ROD. SURGEON WAS ABLE TO USE A DIFFERENT SCREW TO COMPLETE THE PROCEDURE, NO HARM TO PATIENT. CONSULTANT ALSO REPORTED, PRIOR TO THE PROCEDURE, WHILE LOADING, THE TIP OF THE PROTECTION SLEEVE BROKE DURING ASSEMBLY.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123398 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6762960

    Patients

    Seq Age Sex Outcome Treatment
    1