BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOXED CHISEL

    MDR report key: 3810254 · Received April 28, 2014

    Report

    Report Number
    9613350-2014-03472
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    FZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE AFFECTED DEVICE FOR REVIEW. THE LOT NUMBER WAS RECEIVED FOR THE DEVICE, AND THE DEVICE HISTORY RECORDS WAS REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY (EXACT DATE OF SURGERY NOT REPORTED), METAL WAS FALLING OFF THE INSTRUMENT WHILE PERFORMING SURGERY. IT WAS ALSO COMMUNICATED THAT NO BROKE PARTS OF THE INSTRUMENT WENT INTO THE WOUND OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253652 BOXED CHISEL BOXED CHISEL FZO ZIMMER GMBH 08.408575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other