BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3061455 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10924
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    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)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    CONSULTANT REPORTS, DURING AN INTER-MEDULLARY NAIL PROCEDURE OF THE FEMUR, THE INSERTION HANDLE 357.411 AND THE 135DEG AIMING ARM 357.367 DID NOT LINE UP WITH THE NAIL. THE SURGEON LEFT THE NAIL IN WITHOUT THE LOCKING BOLT. THERE WAS NOTHING BROKEN INTO THE WOUND, NOTHING TO RETRIEVE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163538 135 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1