BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDULLARY PLUG WITH DRAIN 4

    MDR report key: 7192929 · Received January 16, 2018

    Report

    Report Number
    0009613350-2018-00096
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 20, 2017
    Report Date
    August 24, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZN
    PMA / PMN Number
    PK830949
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF: 3224 LOT: 2911688. YIELD: 171. DELIVERED: 108. SCRAPPED: 63. REASON FOR SCRAPPING: RE-VALIDATION, USED FOR INTERNAL PURPOSES THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: HOLE IN BAG. EVENT DESCRIPTION: IT WAS REPORTED THAT A HOLE WAS IN THE OUTER STERILE BAG (AVP). FURTHERMORE IT WAS REPORTED THAT THE INNER STERILE BAG (IVP) AND THE PROTECION BAG (SVP) SHOWED NO DAMAGES. REVIEW OF RECEIVED DATA: RECEIVED PICTURES CONFIRM A SMALL HOLE IN THE OUTER BAG (AVP). NO PICTURES FROM THE OTHER BAGS HAVE BEEN RECEIVED. DEVICES ANALYSIS: THE VISUAL EXAMINATION OF THE OUTER BAG (AVP) SHOWS A SMALL HOLE OF AROUND 5MM IN THE MIDDLE OF THE OUTER BAG (AVP). ONLY ONE SIDE IS PUNCTURED. NO OTHER CONSPICUOUSNESS COULD BE FOUND. NEITHER THE INNER BAG (IVP), THE PROTECTION BAG (SVP) NOR THE PACKAGING BOX WERE RETURNED. REVIEW OF PRODUCT DOCUMENTATION: IN THE FINISH (DEPARTMENT FOR PACKING THE PRODUCT) THE SPECIFICATIONS WORK-INSTRUCTION DOCUMENTS REQUIRE A VISUAL EXAMINATION OF THE BAGS. CONCLUSION SUMMARY: IT WAS REPORTED THAT A HOLE WAS IN THE OUTER STERILE BAG (AVP). FURTHERMORE IT WAS REPORTED THAT THE INNER STERILE BAG (IVP) AND THE PROTECTION BAG (SVP) SHOWED NO DAMAGES. THE VISUAL EXAMINATION OF THE OUTER BAG (AVP) SHOWS A SMALL HOLE OF AROUND 5MM IN THE MIDDLE OF THE OUTER BAG (AVP). ONLY ONE SIDE IS PUNCTURED. NO OTHER CONSPICUOUSNESS COULD BE FOUND. NEITHER THE INNER BAG (IVP), THE PROTECTION BAG (SVP) NOR THE PACKAGING BOX WERE RETURNED FOR A MORE DETAILED ANALYSIS. SUCH A DAMAGED PACKAGING IS CLEARLY VISIBLE AND WOULD BE DETECTED WITHIN ZIMMER BIOMET. WHILE THE SEALING PROCESS IS PERFORMED THE EMPLOYEE VERIFIES THE CORRECT SEALING OF EACH BAG. EVERY BAG WILL BE VERIFIED BY THE PACKAGING OPERATOR. A HOLE WITH THIS BIG DIAMETER WOULD BE DETECTED INSIDE THE CLEAN ROOM. FURTHERMORE, THE PACKAGING OF THESE PRODUCTS IS IN USE SINCE MANY YEARS. THE PACKAGING VALIDATION WAS SUCCESSFULLY CONDUCTED. THE COMPLAINT HISTORY SHOWED THAT NO OTHER PACKAGING COMPLAINT HAS BEEN RECEIVED OF THE REPORTED ITEM NO. THEREFORE THIS EVENT CAN BE CONSIDERED AS A SINGLE CASE. MOST LIKELY THE PACKAGING WAS DAMAGED AFTER THE RELEASE OF THE PART. IT CAN BE ASSUMED THAT A WRONG HANDLING OR A TRANSPORTATION ISSUE LED TO THAT ERROR PATTERN OR THAT THE STAFF IN THE OPERATING ROOM OPENED THE OUTER POUCH (WHICH IS A PART OF THE STERILE BARRIER) WITH AN INSTRUMENT SUCH AS A FORCEPS. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD NOT IDENTIFY A SPECIFIC ROOT CAUSE FOR THE OCCURRED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). .

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017 A HOLE IN THE STERILE PACKAGING OF A MEDULLARY PLUG WITH DRAIN 4 WAS NOTICED. IT WAS ALSO REPORTED THAT THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41464 MEDULLARY PLUG WITH DRAIN 4 POLYETHYLENE MEDULLARY PLUG - STIIHMER LZN ZIMMER GMBH N/A 2911688

    Patients

    Seq Age Sex Outcome Treatment
    1