BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOXED CHISEL

    MDR report key: 4172404 · Received October 10, 2014

    Report

    Report Number
    9613350-2014-03986
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    FZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE DEVICE AND PHOTOS FOR REVIEW. WHERE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOXED CHISEL INSTRUMENT WAS BROKEN DURING SURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642658 BOXED CHISEL BOXED CHISEL FZO ZIMMER GMBH 14.999059

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R