BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9MM UNILIF BONE INSERTER

    MDR report key: 3800109 · Received May 8, 2014

    Report

    Report Number
    3004024955-2014-00006
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION. RESULTS: THE IFU FOR SPECIALTY INSTRUMENTS INDICATES THAT THE LIFE OF ANY INSTRUMENT DEPENDS ON HOW OFTEN THE INSTRUMENT IS USED AND INSTRUMENTS SHOULD BE CAREFULLY CHECKED FOR SIGNS OF WEAR PRIOR TO USE. THE SALES REP INDICATED THAT THIS DEVICE HAS BEEN USED APPROXIMATELY 2 TIMES PER WEEK FOR THE PAST 5 YEARS. THE LIKELY CAUSE OF THIS INSTRUMENT IS NORMAL WEAR - SPECIFICALLY REPEATED FATIGUE LOAD OVERTIME. CONCLUSION: THE 9MM UNILIF BONE INSERTER TIP FRACTURE WAS CONFIRMED UPON VISUAL INSPECTION OF THE DEVICE. NO HARM OR DELAY WAS REPORTED FOR THIS EVENT. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON USED 9MM UNILIF INSERTER TO PUT A GRAFT IN THE PATIENT. ONE OF THE ARMS ON THE TIP OF THE INSERTER BROKE OFF. ANOTHER INSERTER WAS USED AND FINISHED THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON USED 9MM UNILIF INSERTER TO PUT A GRAFT IN THE PATIENT. ONE OF THE ARMS ON THE TIP OF THE INSERTER BROKE OFF. ANOTHER INSERTER WAS USED AND FINISHED THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278706 9MM UNILIF BONE INSERTER INSTRUMENT-INSERTER LXH STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR