BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP- GPS DUAL TIP MALABLE 20GAX4IN

    MDR report key: 6746341 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05091
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    November 8, 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
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE PRODUCT CODE- KYZ. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED PICTURES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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. 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 EXPIRY DATES ON IMPLANT STICKERS AND OUTER PACKAGING WAS NOT MATCHING. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529136 SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP- GPS DUAL TIP MALABLE 20GAX4IN SYRINGE, IRRIGATING (NON DENTAL) KYZ BIOMET ORTHOPEDICS N/A 170250

    Patients

    Seq Age Sex Outcome Treatment
    1