BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT RIGHT ANGLE DRIVE

    MDR report key: 2941784 · Received December 21, 2012

    Report

    Report Number
    1811755-2012-04303
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A RADIOLUCENT RIGHT ANGLE DRIVE WAS SENT FOR EVAL BECAUSE IT WAS STRIPING DRILL BITS DURING A PROCEDURE. NO METAL SHAVING WAS REPORTED, NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. HOWEVER, DURING PERFORMANCE TESTING, METAL SHAVING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOLUCENT RIGHT ANGLE DRIVE HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK