BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED GUIDE WIRE

    MDR report key: 3883038 · Received November 2, 2013

    Report

    Report Number
    3003506883-2013-10046
    Event Type
    Malfunction
    Date Received
    November 2, 2013
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWC
    PMA / PMN Number
    K982222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. DEVICES 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. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THIS REPORT IS ASSOCIATED WITH REPORTS: 1719045-2011-00239, 1719045-2011-00240, 3003506883-2013-10045.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SCFE PROCEDURE 2 DRILL BIT TIPS BROKE OFF. WHEN BACKING OUT THE FIRST DRILL BIT IT WAS NOTICED THE TIP WAS BROKEN. THE BROKEN TIP WAS STILL ATTACHED TO THE GUIDE WIRE AND WAS RETRIEVED FROM PATIENT. A SECOND DRILL BIT WAS USED AND WHILE BACKING OUT IT WAS NOTICED THE TIP HAD BROKEN OFF AS WELL. THE BROKEN TIP COULD NOT BE RETRIEVED AND REMAINS IN PATIENT'S LEFT HIP. ADDITIONALLY THE GUIDE WIRES WERE STUCK IN THE TIP OF THE DRILL BITS AND WERE PULLED OUT DURING DRILLING. THIS CAUSED A MINOR DELAY IN THE PROCEDURE TO RE-INSERT THE GUIDE WIRES. THIS REPORT IS FOR COMPLAINT (B)(4) FOR A 2.8M THREADED GUIDE WIRE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565499 2.8MM THREADED GUIDE WIRE HWC SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR