BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM

    MDR report key: 3056669 · Received April 12, 2013

    Report

    Report Number
    0009610622-2013-00180
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE GUIDE WIRE WAS NOT RETURNED FOR EVALUATION; ACCORDING TO INFORMATION RECEIVED THE SUBJECT ITEM WAS DISCARDED BY THE CUSTOMER. THUS, A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT THE REPORTED EVENT COULD NOT BE CONFIRMED. REVIEW OF THE MANUFACTURING DOCUMENTS FOR THE SUBJECT DEVICE REVEALED NO DISCREPANCIES. WITH THE INFORMATION GIVEN THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THERE ARE NO OPEN ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN OPENING THE PACKAGE THAT THE PLASTIC PACKAGE AND THE PAPER PACKAGE INSIDE WERE STUCK TOGETHER. THE NURSE USED FORCE TO PULL THE PAPER PACKAGE OUT OF THE PLASTIC PACKAGE, THEN THE PAPER PACKAGE TORE THUS THE STERILITY WAS QUESTIONED. A BACKUP PRODUCT WAS USED.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN OPENING THE PACKAGE THAT THE PLASTIC PACKAGE AND THE PAPER PACKAGE INSIDE WERE STUCK TOGETHER. THE NURSE USED FORCE TO PULL THE PAPER PACKAGE OUT OF THE PLASTIC PACKAGE, THEN THE PAPER PACKAGE TORE THUS THE STERILITY WAS QUESTIONED. A BACKUP PRODUCT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158841 GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K116279

    Patients

    Seq Age Sex Outcome Treatment
    1 Other