BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, RECON 3.2X400 MM

    MDR report key: 2003069 · Received February 8, 2011

    Report

    Report Number
    9610622-2011-00046
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HTY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL SURGERY, TO INSERT LAG SCREW AFTER NAIL HAD BEEN INSERTED, THE SURGEON INSERTED GUIDE WIRE. AFTERWARDS, THE SURGEON REMOVED GUIDE WIRE TO CORRECT THE POSITION OF GUIDE WIRE AND INSERTED IT AGAIN. THE TIP OF GUIDE WIRE (ABOUT 5MM) BROKE WHILE SURGEON WAS INSERTING GUIDE WIRE. THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, RECON 3.2X400 MM INSTRUMENT HTY STRYKER OSTEOSYNTHESIS KIEL NA K143283

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other