BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF UNI TIB TRAY SZ F RM PMA

    MDR report key: 7504014 · Received May 10, 2018

    Report

    Report Number
    3002806535-2018-00792
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    May 24, 2017
    Report Date
    March 7, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE QUALITY ENGINEER FOR INVESTIGATION. THE DHR FOR THE INVOLVED PRODUCT HAS BEEN REVIEWED AND DOES NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE INNER POUCH HAS BEEN BREACHED. THE BATCH WAS MANUFACTURED IN 2012 AND IT CANNOT BE DETERMINE HOW MANY TIMES THE PRODUCT HAS BEEN TRANSPORTED AND ALSO HOW IT WAS HANDLED. NO FURTHER COMPLAINTS WERE FOUND FOR THIS ITEM BATCH COMBINATION.

    Description of Event or Problem · 0

    INNER PACKAGE HAD HOLE IN PLASTIC.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGE WAS OPENED AND THE INNER PACKAGE HAD HOLE IN PLASTIC WITH WHITE FLAKY MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347518 OXF UNI TIB TRAY SZ F RM PMA JWH BIOMET UK LTD. N/A 2613313

    Patients

    Seq Age Sex Outcome Treatment
    1