BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 3052137 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10721
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS (B)(4) 2012.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PLANNED ELASTIC NAIL REMOVAL, THE SURGEON WAS REPORTEDLY TRYING TO REMOVE THE TI ELASTIC NAIL. AS THE SURGEON WAS HAMMERING, THE THREADED END PORTION OF THE 359.218 EXTENSION BROKE OFF AND THE THREADS WERE STILL ATTACHED IN THE CHUCK 359.219. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT USING OTHER INSTRUMENTATION. THE CONSULTANT PROVIDED LOANER INSTRUMENTS FROM THE METRO OFFICE TO USE IF NEEDED BEFORE REPLACEMENTS ARRIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156146 INSERTER FOR TI ELASTIC NAILS LXH SYNTHES GMBH 3098634

    Patients

    Seq Age Sex Outcome Treatment
    1