BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP CONICAL REAMER 13 MM

    MDR report key: 1071834 · Received July 8, 2008

    Report

    Report Number
    9610622-2008-00108
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 16, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HTO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON INSERTED A 3X235MM K-WIRE AT THE TIP OF THE GREATER TROCHANTER. ONCE SHE ACHIEVED SATISFACTORY POSITION, SHE REAMED OVER THE K-WIRE WITH THE ONE-STEP CONICAL REAMER 13 0. AS SHE CONTINUED TO REAM, THE SHAFT OF THE REAMER SNAPPED, AND THE END OF THE REAMER WAS LEFT IN THE DRILL. THE REST OF THE ONE-STEP REAMER WAS REMOVED, FLEXIBLE REAMERS WERE USED FOR THE ENTRY POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE STEP CONICAL REAMER 13 MM INSTRUMENT HTO STRYKER OSTEOSYNTHESIS KIEL NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other