BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 3183108 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00958
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    November 4, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE SCREW HEAD HAS DISENGAGED AS COMPLAINED. NO MANUFACTURING RELATED ISSUES WERE FOUND. FURTHER INVESTIGATIONS HAVE SHOWN THAT THE COLLET IS ROTATED AND THEREFORE JAMMED. DUE TO PREVIOUSLY RECEIVED MARKET FEEDBACK, THE FAILURE OF THIS PHENOMENON HAS ALREADY BEEN IDENTIFIED. IN THIS REGARD WE WOULD LIKE TO POINT OUT THAT IT IS VERY IMPORTANT TO USE THE HEAD ALIGNMENT TOOL TO ROTATE AND ALIGN THE SCREW HEADS. NEVERTHELESS, IN TERMS OF CONTINUOUS IMPROVEMENT A DESIGN CHANGE HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW WAS INSERTED AND WHEN THE SURGEON TRIED TO REMOVE THE SCREWDRIVER, THE HEAD WAS STUCK ON THE SCREWDRIVER AND DISENGAGED FROM THE SCREW. NO FORCE WAS USED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282716 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM NKB SYNTHES BRANDYWINE 6430439

    Patients

    Seq Age Sex Outcome Treatment
    1