BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6746340 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05090
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    December 15, 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS MALFUNCTION HAS NOT PREVIOUSLY CAUSED A SERIOUS INJURY.

    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. PRODUCT NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXPIRATION DATES ON IMPLANT STICKERS AND OUTER PACKAGING DID NOT MATCH. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529135 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