BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL STEM INSERTER

    MDR report key: 4221771 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04157
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE REPORTED DEVICE WAS NOT INTENDED TO BE DISASSEMBLED FOR CLEANING OR STERILIZATION. THE DEVICE WAS MANUFACTURED IN 2008 TO THE (B)(4) PRIOR TO THE DESIGN CHANGE IN 2011 WHICH ENABLES DISASSEMBLY. THE DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    UNABLE TO DISMANTLE FOR CLEANING PRIOR TO STERILISATION NOT VALIDATED AS STERILE BY HOSPITAL.

    Description of Event or Problem · 1

    UNABLE TO DISMANTLE FOR CLEANING PRIOR TO STERILISATION NOT VALIDATED AS STERILE BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703955 DISTAL STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TACJ70B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other