BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6746339 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05092
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Report Date
    November 9, 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
    PHYSICIAN

    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. PRODUCT IS NOT BEING RETURNED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS NO PATIENT INJURY OCCURRED, AND THIS ISSUE IS NOT LIKELY TO LEAD TO A SERIOUS INJURY IF THE EVENT WERE TO REOCCUR. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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 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
    526514 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