BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR REVERSE LINER +6 MM

    MDR report key: 11601129 · Received April 1, 2021

    Report

    Report Number
    3008021110-2021-00024
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 25, 2021
    Report Date
    August 20, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY CHECKING THE DHR OF THE LOT NUMBER 19AT06N, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. WE RECEIVED THE COMPONENT INVOLVED IN THE EVENT FOR ADDITIONAL INVESTIGATION. BY INSPECTION OF THE COMPONENT, THE PACKAGING APPEARED TO BE PERFECTLY INTACT (THUS THE PACKAGING WAS NOT OPEN) AND THE COMPONENT DID NOT SHOW ANY TRACE OF "BIOLOGICAL MATERIAL" THAT COULD HAVE CONTAMINATED THE PIECE ITSELF. THEREFORE, THE MOST PLAUSIBLE HYPOTHESIS SEEMS TO BE THAT THE HAIR NOTICED INTRA-OPERATIVELY WAS ON THE SURFACE OUTSIDE THE PACKAGING. HENCE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING AND THE STERILIZATION CHARTS OF THE COMPONENT INVOLVED IN THE EVENT - AFTER RECEIVING THE COMPONENT, WE DID NOT SEE ANY "BIOLOGICAL MATERIAL" INSIDE THE PACKAGE, WHICH APPEARED PERFECTLY INTACT. THEREFORE, THE HAIR WAS PROBABLY ON THE OUTSIDE OF THE PACKAGE. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, THIS IS THE FIRST AND ONLY COMPLAINT WHICH HAS INVOLVED A SMR REVERSE LINER (BELONGING TO THE FAMILY PRODUCT CODES 1360.50.XXX, 1361.50.XXX, 1365.50.XXX) ABOUT A SUSPECTED PACKAGING ISSUE. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE HAS ANYWAY PERFORMED SOME GENERAL AWARENESS ACTIVITIES, BUT NOT STRICTLY RELATED TO THIS EVENT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, AFTER THE SMR REVERSE LINER +6 MM (PART CODE 1360.50.820, LOT NUMBER 19AT06N, STERILIZATION 2000293) WAS OPENED ONTO STERILE FIELD, IT WAS NOTED THAT THE INNER STERILE PACKAGING HAD A HAIR ON IT. INNER PACKAGE WAS NOT OPENED BUT REMOVED FROM FIELD. INSTRUMENTS IN CONTACT WITH IMPLANT PACKAGING WERE REMOVED, ANTIMICROBIAL DRAPE WAS PLACED OVER BACK TABLE AND NEW INSTRUMENTS WERE INTRODUCED ONTO FIELD. SURGERY WAS DELAYED BY 5 MINUTES. THE PATIENT IS A FEMALE, 78 YEARS OLD. EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #19AT06N, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, AFTER THE SMR REVERSE LINER +6 MM (PRODUCT CODE 1360.50.820, LOT# 19AT06N - STER. 2000293) WAS OPENED ONTO STERILE FIELD, IT WAS NOTED THAT THE INNER STERILE PACKAGING HAD A HAIR ON IT. INNER PACKAGE WAS NOT OPENED BUT REMOVED FROM FIELD. INSTRUMENTS IN CONTACT WITH IMPLANT PACKAGING WERE REMOVED, ANTIMICROBIAL DRAPE WAS PLACED OVER BACK TABLE AND NEW INSTRUMENTS WERE INTRODUCED ONTO FIELD. SURGERY WAS DELAYED OF 5 MINUTES. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501482 SMR REVERSE LINER +6 MM REVERSE LINERS 36MM (UHMWPE) +6MM KWS LIMACORPORATE S.P.A. 1360.50.820 19AT06N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other