BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MIXING BOWLS WITH SPATULA

    MDR report key: 4751470 · Received May 1, 2015

    Report

    Report Number
    1526350-2015-00085
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED ON 05/20/2015 IN A PLASTIC ZIP LOCK BAG. THE SPATULA AND POUCH AND THE MIXING BOWL WERE RETURNED. THE CONTAMINATION WAS CAPTURED AND SAVED ON TWO STICKY TABS AND WAS INSIDE THE SPATULA POUCH. NO OBVIOUS DAMAGE WAS VISIBLE WITH THE RETURNED PRODUCT. THE EVALUATION OF THE CONTAMINATION THAT WAS RETURNED WITH THE DEVICE APPEARS TO BE PLASTIC - MOST PROBABLY FLASHING FROM THE SPATULA. THIS EVALUATION WAS ACCOMPLISHED USING A DIGITAL ELECTRONIC MICROSCOPE. THE CUSTOMERS REPORTED EVENT WAS FOREIGN MATERIAL WAS FOUND INSIDE THE POUCH OF THE SPATULA. THE INFORMATION PROVIDED AND THE RETURNED PRODUCT CONFIRM THAT CONTAMINANT WAS FOUND BY THE CUSTOMER. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) NOTED NO NON-CONFORMANCES. REQUESTS FOR DEVIATION (RPD'S) OR OTHER ISSUES. THE QUALITY RECORDS SHOW THAT THIS LOT WAS PREPARED IN ACCORDANCE WITH THE REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM AND ALL THE QUALITY CONTROL TESTS WERE PASSED SUCCESSFULLY. ADDITIONALLY, THE REVIEW OF THE MANUFACTURING PROCESS NOTED NO SYSTEMIC ISSUES. THE PARTICULATE IS LARGER THAN THE ALLOWABLE SIZE ACCORDING TO THE PROCEDURE. THE MOST LIKELY CAUSE FOR THIS CONTAMINATION IS FLASHING ON THE SPATULA WAS SLOUGHED OFF AND CAPTURED IN THE SEALED POUCH DURING HANDLING AND TRANSIT AFTER PACKAGING.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED, ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATERIAL GOT MIXED WITHIN THE PACKAGING OF THE SPATULA. ADDITIONAL INFO OBTAINED INDICATED THAT THE REPORTED CONTAMINATED PRODUCT ENTERED THE STERILE FIELD. THE CUSTOMER USED AND FINISHED THE SURGERY WITH AN ALTERNATIVE ONE. THERE WAS NO PATIENT HARM OR DELAYS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289477 DISPOSABLE MIXING BOWLS WITH SPATULA DISPOSABLE MIXING BOWLS WITH SPATULA GAF ZIMMER SURGICAL NA 62735851

    Patients

    Seq Age Sex Outcome Treatment
    1