BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GPS DUAL TIP MALABLE 20GAX4IN

    MDR report key: 6612042 · Received June 5, 2017

    Report

    Report Number
    0001825034-2017-03616
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    May 9, 2017
    Report Date
    December 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KYZ
    PMA / PMN Number
    PK940371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, THIS MALFUNCTION WAS FOUND TO HAVE NEVER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY AND SHOULD BE NONREPORTABLE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURE. 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. DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE - KYZ. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPIRATION DATES ON THE IMPLANT STICKERS AND OUTER PACKAGING DID NOT MATCH. THE IMPLANT STICKERS HAD ON THE INCORRECT EXPIRATION DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394293 GPS DUAL TIP MALABLE 20GAX4IN SYRINGE, IRRIGATING (NON DENTAL) KYZ BIOMET ORTHOPEDICS 170250

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR