BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, COCR, RECON T2 RECON Ø3.2X400 MM

    MDR report key: 4123978 · Received September 27, 2014

    Report

    Report Number
    0009610622-2014-00511
    Event Type
    Malfunction
    Date Received
    September 27, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FEMORAL SHAFT FRACTURE SURGERY, SURGEON WAS DRILLING K-WIRE INTO FEMORAL HEAD. K-WIRE BROKE OFF IN THE FEMORAL HEAD. SALES REP INDICATED THAT THREE WIRES WERE UTILIZED AND IT IS NOT CLEAR WHICH WIRE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603760 K-WIRE, COCR, RECON T2 RECON Ø3.2X400 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K902171

    Patients

    Seq Age Sex Outcome Treatment
    1 26 Other