BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, RECON 3.2X400 MM

    MDR report key: 2245480 · Received June 29, 2011

    Report

    Report Number
    9610622-2011-00281
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICE WAS DISCARDED. THREE DIFFERENT LOT'S WERE USED. IT IS NOT KNOWN WHICH LOT BROKE - K390261, K149293, K299157.

    Description of Event or Problem · 1

    WIRE BROKE OFF INTER-OPERATIVELY. NO FURTHER INFO KNOWN AT THIS STAGE. TIP OF WIRE LEFT IN PT, REST OF OPERATION CONTINUED AS NORMAL. NO ADVERSE CONSEQUENCES TO THE PT BECAUSE OF THE TIP BEING LEFT IN THE PT. THE REST OF THE WIRE WAS NOT KEPT, RATHER IT WAS DISPOSED OF WITH THE SHARPS WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, RECON 3.2X400 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other