BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH

    MDR report key: 3032401 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-10656
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE WIRE BROKE OFF 3MM BELOW THE BALL. THE SHAFT OF THE WIRE WAS BENT IN TWO PLACES AS WELL AS SIGNS OF GAULING FROM THE WIRE DRIVER IN TWO PLACES. SINCE IT IS NOT POSSIBLE TO DETERMINE THE STATIC/FATIGUE LOADING ON THE INSTRUMENT, NOR THE AMOUNT OF TIMES THE INSTRUMENT MIGHT HAVE BEEN USED BEFORE THE FAILURE, THIS COMPLAINT IS DEEMED INVALID. THE SHAFT OF THE COMPRESSION WIRE SHOWS WEAR AND MARKS. THE LOT NUMBER IS IRRECOGNIZABLE DUE TO THE FRETTING MARKS; A DHR REVIEW THEREFORE IS NOT POSSIBLE. THE OUTSIDE DIAMETER MEETS THE SPECIFICATIONS AND THE MICROSCOPIC VIEW SHOWS A CORRECT THREAD AND TIP. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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. ORIGINAL AWARENESS DATE IS 3/12/12. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALCANEOCUBOID FUSION, THE SURGEON INSERTED THE 1.6MM COMPRESSION WIRE THROUGH THE PLATE AND THE COMPRESSION WIRE BROKE DURING THE REMOVAL FROM THE PLATE. THE SURGEON RETRIEVED THE BROKEN FRAGMENT, AND USED ANOTHER COMPRESSION WIRE TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PROBLEMS AND NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136685 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH HWN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1