BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM

    MDR report key: 3061820 · Received April 16, 2013

    Report

    Report Number
    3003506883-2013-10109
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    LRN
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). 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. 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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING THE GUIDE WIRE, DURING AN OSTEOTOMY, HIP, THE WIRE GOT STUCK IN THE PLATE. AS THE SURGEON TRIED TO WORK THE WIRE FREE, IT BROKE. THE WIRE BROKE ABOVE THE PLATE, NOT IN THE PATIENT. THE WIRE WAS REMOVED FROM THE PLATE WITH PLIERS AND ALL PIECES WERE RETRIEVED. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161897 2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM LRN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR