BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM THREADED GUIDE WIRE 150MM

    MDR report key: 4154610 · Received October 9, 2014

    Report

    Report Number
    2520274-2014-14017
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PPREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES: JDW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY A 1.6MM WIRE FOR A 4.5MM CANNULATED SCREW BROKE WHEN IT WAS INSERTED INTO THE BONE. THE SURGEON WAS USING A STRYKER CORDLESS DRILL. THE BROKEN PART OF THE WIRE WAS NOT RETRIEVED BY THE SURGEON AND REMAINS IN THE PATIENT. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN SURGERY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635388 1.6MM THREADED GUIDE WIRE 150MM WIRE, SURGICAL LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR