BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO CONNECTOR ADAPTOR

    MDR report key: 4535361 · Received February 23, 2015

    Report

    Report Number
    0009617544-2015-00076
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K103292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED LOT CODE: 133835. METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: MATERIAL ANALYSIS WAS PERFORMED IT WAS DETERMINED THAT GALLING WAS THE CAUSE OF THE SEIZURE OF THE LOCKING NUT. ADDITIONALLY, NO MANUFACTURING DEFECTS WERE OBSERVED DURING THE ANALYSIS. REMOVAL OF THE SEIZED LOCKING NUT LIKELY CAUSED THE DEFORMATION OBSERVED ON THE THREADS. CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS GALLING BETWEEN THE SCREW AND NUT THREADS CAUSING THE DEVICE TO JAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING TRIO TRAUMA SURGERY, THE SURGEON CORRECTED KYPHOSIS OF THE PATIENT. WHEN THE SURGEON TRIED TO TIGHTEN THE NUT OF CONNECTOR ADAPTER, THE NUT DID NOT TIGHTEN. THEREFORE, THE SURGEON TRIED TO LOOSEN THE NUT OF CONNECTOR ADAPTER, BUT THE SURGEON COULD NOT LOOSEN. THE SURGEON CHANGED THE CONNECTOR ADAPTER TO ANOTHER CONNECTOR ADAPTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING TRIO TRAUMA SURGERY, THE SURGEON CORRECTED KYPHOSIS OF THE PATIENT. WHEN THE SURGEON TRIED TO TIGHTEN THE NUT OF CONNECTOR ADAPTER, THE NUT DID NOT TIGHTEN. THEREFORE, THE SURGEON TRIED TO LOOSEN THE NUT OF CONNECTOR ADAPTER, BUT THE SURGEON COULD NOT LOOSEN. THE SURGEON CHANGED THE CONNECTOR ADAPTER TO ANOTHER CONNECTOR ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125112 TRIO CONNECTOR ADAPTOR PEDICLE SCREW SPINAL SYSTEM MNH STRYKER SPINE-FRANCE 133835

    Patients

    Seq Age Sex Outcome Treatment
    1