BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCOOP, F/AUTOPSY-SAW, HOLLOW, 8MM

    MDR report key: 434857 · Received December 19, 2002

    Report

    Report Number
    2916714-2002-00027
    Event Type
    Malfunction
    Date Received
    December 19, 2002
    Date of Event
    December 11, 2002
    Report Date
    December 17, 2002
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    FHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE SCOOP BROKE DURING SURGERY. THE BROKEN PIECE WAS RETRIEVED. SURGERY WAS EXTENDED TEN MINUTES. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE SCOOP, F/AUTOPSY-SAW, HOLLOW, 8MM SCOOP FHL AESCULAP AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention