BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR WIRE Ø1.6 L150/30

    MDR report key: 3161344 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03267
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 31, 2012
    Report Date
    June 1, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2013; COMPRESSION WIRE SHEARED OFF JUST ABOVE THE OLIVE, THROUGH THE PLATE WITH A POWERTOOL AND INTO THE BONE. IT WAS ALSO REPORTED THIS WAS NOT DONE AT AN ANGLE AND THE EVENT OCCURRED WHEN WIRE WAS REPOSITIONED FOR THE THIRD TIME. THE SURGEON REMOVED THE WIRE WITH A PAIR OF PLIERS AND WAS DISCARDED. PROCEDURE WAS COMPLETED WITH ANOTHER SET OF WIRES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262514 COMPR WIRE Ø1.6 L150/30 HWN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1