BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLAT CURVED CHISEL, 16MM

    MDR report key: 4751509 · Received May 1, 2015

    Report

    Report Number
    9613350-2015-00502
    Event Type
    Other
    Date Received
    May 1, 2015
    Date of Event
    January 27, 2015
    Report Date
    April 20, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    EML
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. HANDLES MADE OUT OF CANEVASIT LEADS TO DISCOLORATION/RESIDUES. AS INVESTIGATING TO THE CASE AT HAND, ZIMMER (B)(4) FOUND PARALLELS BETWEEN THIS EXPERIENCE AND THAT OF OTHER USERS OF CANEVASIT HANDLES. AS A REACTION TO THOSE EARLIER REPORTS ZIMMER (B)(4) ALREADY PERFORMED A CONCISE ANALYSIS AND HAVE BEEN ABLE TO IDENTIFY THE ROOT CAUSE THAT ALSO EXPLAINS THE EVENT OF THAT EXPERIENCE. THE ROOT CAUSE IS INAPPROPRIATE PRODUCT SPECIFICATIONS. APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS WERE ALREADY IMPLEMENTED. THE HANDLE MATERIAL OF IDENTIFIED INSTRUMENTS WAS CHANGED FROM CANEVASIT TO PPSU OR METAL. AS ERROR PATTERN AND ROOT CAUSE ARE ALREADY KNOWN AND APPROPRIATE MEASURES WERE TAKEN, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION 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 "THE MEDICAL DEVICES WITH HANDLES MADE OF FERROZELL MATERIAL LEAD TO DISCOLORATION/RESIDUES IN THE CONTAINER AFTER THE STERILIZATION AND INSTRUMENTS THAT CAN BE HYGIENICALLY QUESTIONABLE, OR AT LEAST MAKING THE USER AND (B)(6) STAFF UNCOMFORTABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289453 FLAT CURVED CHISEL, 16MM FLAT, CURVED CHISEL, 16MM EML ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other