BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT

    MDR report key: 3171621 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02958
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    December 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION OF THE TWO RETURNED SYNFRAME GUIDE RODS HAS SHOWN THAT ONE IS IN WORKING ORDER AND THE OTHER ONE IS BROKEN OFF. THE CLAMPING SURFACE BELOW OF THE HEXAGON HAS BEEN COMPLETELY COMPRESSED. THESE ARE CLEAR SIGNS THAT THIS INSTRUMENT WAS SUBJECTED TO TREMENDOUS FORCES AND THAT OVER TIGHTENING OF THE SCREW CAUSED THE BREAKAGE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, ISSUES WERE NOTED WITH TWO SYNFRAME GUIDE ROD DEVICES. ONE IS NOT INSERTING A RETRACTOR INTO THE END OF THE GUIDE ROD. THE OTHER IS NOT TIGHTENING THE SWIVELING CAMP OF THE GUIDE ROD USING THE SOCKET WRENCH. IT IS UNKNOWN WHERE THESE ISSUES OCCURRED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272504 SYNFRAME GUIDE ROD W/ADJUST-CLAMP F/SOFT LXH SYNTHES GMBH 2735625

    Patients

    Seq Age Sex Outcome Treatment
    1