BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER

    MDR report key: 752312 · Received May 16, 2005

    Report

    Report Number
    MW1035497
    Event Type
    Other
    Date Received
    May 16, 2005
    Date of Event
    May 10, 2005
    Report Date
    May 16, 2005
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAVING RIGHT TOTAL KNEE ARTHOPLASTY. SURGEON USING SAW AND BONE CRACKED. PHYSICIAN DOCUMENTS "THE SAW BROKE CAUSING A SMALL CRACK IN THE LATERAL FEMORAL CONDYLE, WHICH WAS NOT IN THE WEIGHTBEARING AND DID NOT SEEM OF ANY CONSEQUENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ORTHO SAW BLADE HWE STRYKER ORTHOPAEDICS 2108-351 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other