BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE T HANDLE

    MDR report key: 3970189 · Received July 31, 2014

    Report

    Report Number
    0009617544-2014-00342
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE IFU FOR INSTRUMENTS STATES THE INSTRUMENTS MAY FRACTURE DEPENDING ON THE NUMBER OF TIMES THEY ARE USED AS WELL AS THE PRECAUTIONS TAKEN IN HANDLING, CLEANING AND STORAGE. ALSO, INSTRUMENTS WITH ARTICULATIONS MAY REQUIRE LUBRICATION. THE T-HANDLE FRACTURED AS A RESULT OF MIXED CLEAVAGE AND DUCTILE OVERLOAD. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS USER RELATED, SPECIFICALLY, APPLYING EXCESSIVE FORCE TO THE T-HANDLE DURING ASSEMBLY.

    Description of Event or Problem · 1

    IT¿S REPORTED THAT DURING SURGERY, THE SURGEON USED THE REAMER DISTRACTOR (10MM). THE REAMER DISTRACTOR WAS ASSEMBLED TO THE T-HANDLE. THE SURGEON WAS NOT ABLE TO REMOVE REAMER DISTRACTOR FROM T-HANDLE AFTER USE. ALTHOUGH THE SURGEON REMOVED REAMER DISTRACTOR FORCIBLY, THE PARTS INSIDE T-HANDLE BROKE. THE SURGEON CHANGED THE T-HANDLE TO ANOTHER T-HANDLE.

    Description of Event or Problem · 1

    IT铠REPORTED THAT DURING SURGERY, THE SURGEON USED THE REAMER DISTRACTOR (10MM). THE REAMER DISTRACTOR WAS ASSEMBLED TO THE T-HANDLE. THE SURGEON WAS NOT ABLE TO REMOVE REAMER DISTRACTOR FROM T-HANDLE AFTER USE. ALTHOUGH THE SURGEON REMOVED REAMER DISTRACTOR FORCIBLY, THE PARTS INSIDE T-HANDLE BROKE. THE SURGEON CHANGED THE T-HANDLE TO ANOTHER T-HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448378 RELIANCE T HANDLE INSTRUMENT-T-HANDLE LXH STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1