BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT DISC SHAVER (INSTRUMENT)

    MDR report key: 4093058 · Received September 10, 2014

    Report

    Report Number
    MW5038179
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) PERFORMING A PLIF PROCEDURE AND APPARENTLY USING A SOFT DISC SHAVER INSTRUMENT FROM ONE OF OUT SETS. WHILE THE INSTRUMENT WAS IN THE PT THE HEAD OF THE SHAVER BROKE OFF. (B)(6) REPORTED THAT HE FELT IT WOULD DO MORE HARM TO THE PT WHILE ATTEMPTING TO RETRIEVE IT SO HE FELT IT BEST TO LEAVE IT IN THE PT. THE PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559848 SOFT DISC SHAVER (INSTRUMENT) SOFT DISC SHAVER (INSTRUMENT) HBB MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR