BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER SHAVER BLADE

    MDR report key: 575855 · Received February 16, 2005

    Report

    Report Number
    575855
    Event Type
    Other
    Date Received
    February 16, 2005
    Date of Event
    February 11, 2005
    Report Date
    February 16, 2005
    Manufacturer
    STERIL MED, INC
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A SMALL TIP OF THE SHAVER WAS NOTED TO BE MISSING INTRAOPERATIVELY. AN X-RAY WAS TAKEN AND THE MISSING PIECE WAS FOUND TO BE IN THE KNEE OF THE PATIENT. IT WAS REMOVED BY THE SURGEON AND A 2ND X-RAY CONFIRMED THAT IT WAS OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SHAVER BLADE SHAVER BLADE HRX STERIL MED, INC STR275-544-000 *
    2 STRYKER SHAVER BLADE SHAVER BLADE HRX STRYKER ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR