BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET BIOLOGICS APPLICATOR

    MDR report key: 6816270 · Received August 24, 2017

    Report

    Report Number
    0001825034-2017-06754
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    November 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KYZ
    PMA / PMN Number
    PK940371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PACKAGING WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. DEVICE NAME: KYZ. IMPLANTED DATE: NOT APPLICABLE. EXPLANTED DATE: NOT APPLICABLE. NO PRODUCT IS RETURNED; FROM THE REVIEW OF THE PROVIDED PICTURE DETERMINED THAT THE MANUFACTURING DATE, NOT THE STERILE EXPIRATION DATE, IS PRINTED ON THE PATIENT LABELS. THE EXPIRATION DATE ON THE OUTER LABEL IS CORRECT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE A LABELING DEFICIENCY AT THE SUPPLIER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT WITHIN THE PACKAGING HAD A STERILE DATE THAT WAS DIFFERENT FROM THE DATE ON THE OUTSIDE OF THE PACKAGING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599128 BIOMET BIOLOGICS APPLICATOR SYRINGE, IRRIGATING KYZ BIOMET ORTHOPEDICS N/A 170250

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR