BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL FIBULA PLATE HOLES 6 LENGTH 117MM FOR SCREWS 3.5/4.0MM

    MDR report key: 3902036 · Received June 30, 2014

    Report

    Report Number
    0008031020-2014-00291
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K060798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE BY THE USER COULD BE CONFIRMED SINCE THE DEVICE HAS BEEN EXPIRED 2 MONTHS PRIOR THE IMPLANTATION. NO RISK CAN BE EVALUATED. STRYKER DEVICES ALL PASSED THE TEST FOR SHELF LIFE EXCEEDING 5 YEARS BUT ONLY THIS TIME FOR STERILITY CAN BE GUARANTEED. PLEASE NOTE THAT THE INSTRUCTION FOR USE (V15052 REV C NON-ACTIVE IMPLANT IFU) WAS REVIEWED: ''PRODUCTS DELIVERED STERILE HAVE EITHER BEEN EXPOSED TO A MINIMUM OF 25 KGY OF GAMMA RADIATION FROM A COBALT 60 SOURCE OR HAVE BEEN STERILIZED BY VACUUM STEAM STERILIZATION (PLEASE SEE PRODUCT LABEL FOR STERILIZATION METHOD APPLIED). PRODUCTS NOT LABELLED AS STERILE ARE NON-STERILE. THE PACKAGING OF ALL STERILE PRODUCTS SHOULD BE INSPECTED FOR FLAWS IN THE STERILE BARRIER OR EXPIRATION OF SHELF LIFE BEFORE OPENING.'' [ORIGINAL STATEMENT(S)]. IT'S UP TO THE HEALTHCARE PROFESSIONAL TO PRESCRIBE ADDITIONAL ANTIBIOTICS IN CASE OF A POTENTIAL INFECTION RISK. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION ILL BE REWORKED.

    Description of Event or Problem · 1

    DURING THE SPS SURGERY, THE SURGEON DID NOT NOTICE THAT THE STERILITY DATE HAD BEEN EXCEEDED FOR THE FIBULA PLATE BEING USED. AFTER INSERTING THE PLATE IT WAS NOTICED THAT THE EXPIRE DATE HAD BEEN EXCEEDED. THE SURGEON CHANGED THE PLATE TO ANOTHER 5 HOLE PLATE. THE EXPIRE DATE OF PLATE WAS 4/30/2014.

    Description of Event or Problem · 1

    DURING THE SPS SURGERY, THE SURGEON DID NOT NOTICE THAT THE STERILITY DATE HAD BEEN EXCEEDED FOR THE FIBULA PLATE BEING USED. AFTER INSERTING THE PLATE IT WAS NOTICED THAT THE EXPIRE DATE HAD BEEN EXCEEDED. THE SURGEON CHANGED THE PLATE TO ANOTHER 5 HOLE PLATE. THE EXPIRE DATE OF PLATE WAS (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380633 DISTAL FIBULA PLATE HOLES 6 LENGTH 117MM FOR SCREWS 3.5/4.0MM PLATE, FIXATION, BONE HRS STRYKER GMBH U08955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other