BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM

    MDR report key: 3062898 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-10926
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    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).

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR A DISTAL RADIUS FRACTURE, THE SURGEON TRIED INSERTING THE 1.25 MM PLATE REDUCTION WIRE INTO THE NON-LOCKING HOLE SHAFT OF THE PLATE. WHEN THE SURGEON WAS UNABLE TO GET ENOUGH COMPRESSION, THE WIRE WAS INSERTED INTO THE THREADED HOLE OF THE PLATE AND DURING REMOVAL, THE WIRE BROKE ABOVE THE BALL TIP. BROKEN WIRE WAS RETRIEVED AND THE PLATE WAS LOCKED INTO POSITION. WIRE WAS DISCARDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165740 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1