BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL+SCRGUIDE F/VECTRA+VECTRA-T

    MDR report key: 3161332 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02972
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    August 9, 2012
    Report Date
    August 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 ADDITIONAL EVALUATION REVEALED THAT THE WELDING OF THE POSITION PIN OF THE DRILL AND SCREW GUIDE IS INDEED BROKEN OFF. WE HAVE TO ASSUME, THAT HIGH APPLIED MECHANICAL FORCES CAUSED THE BREAKAGE OF THE SPOT WELDING. PLEASE NOTE, THAT THIS IS A RATHER OLD AND OFTEN USED INSTRUMENT. VISIBLE SIGNS INDICATE OFTEN AND HARD USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDING PEG BECAME LOOSE. THE PEG AT THE PATIENT END OF THE INSTRUMENT DETACHED, AND WAS LEFT IN THE PLATE AFTER THE INSTRUMENT WAS REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263299 DRILL+SCRGUIDE F/VECTRA+VECTRA-T FZX SYNTHES GMBH 1500114

    Patients

    Seq Age Sex Outcome Treatment
    1