BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT

    MDR report key: 3161347 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02987
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    August 22, 2012
    Report Date
    August 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PART BENEATH THE HEX NUT IS INDEED BROKEN OFF. WE DO SUPPOSE THAT FAR TOO MUCH MECHANICAL FORCE (OVER TIGHTENING OF THE HEX PART) HAS BEEN APPLIED AND RESULTED IN THE BREAKAGE OF THE LEAVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE SURGEON TIGHTENED THE ADJUSTABLE CLAMP ON THE GUIDE ROD, THE METAL UNDERNEATH THE HEX NUT BROKE. GUIDE ROD WAS UNABLE TO BE TIGHTENED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262515 SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT LXH SYNTHES GMBH 2769482

    Patients

    Seq Age Sex Outcome Treatment
    1