BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE STRYDE SYSTEM

    MDR report key: 12331580 · Received August 17, 2021

    Report

    Report Number
    3006179046-2021-00447
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 15, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00887517951168
    PMA / PMN Number
    K180503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAIL WAS RECEIVED FOR VISUAL AND FUNCTIONAL TESTING. EXAMINING THE BROKEN NAIL CLOSELY REVEALED THAT THE LOCATION WHERE IT BROKE WAS WHERE THERE ARE HOLES ON EITHER SIDE OF THE NAIL TO INSERT SCREWS. ALSO, THE WAY THE NAIL IS BROKEN, THE BROKEN ENDS ARE NOT STRAIGHT BUT RATHER STRETCHED. THIS COULD INDICATE THE NAIL WAS SUBJECTED TO EXCESSIVE BENDING, RENDERING IT SOFTER AND RESULTING IN ITS BREAKAGE AT THIS LOCATION. THE LOCATION OF THE FAILURE (AT THE TWO HOLES ON EITHER SIDES OF THE NAIL) IS CONSISTENT WITH WHAT WE WOULD EXPECT FROM A MECHANICAL BENDING FAILURE IN FATIGUE. FUNCTIONAL TESTING WAS NOT APPLICABLE DUE TO THE STATUS OF THE NAIL.. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER 9040401 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT. COMPLAINT FAILURE MODE BROKEN NAIL HAS NO CHANGE ORDERS (CO) OR CAPAS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING REMOVAL THE PROXIMAL PART OF THE NAIL BROKE WHEN THE SURGEON UNLOCKED THE END CAP AND THE DISTAL PART OF THE NAIL WAS UNABLE TO BE REMOVED. A SECOND PROCEDURE WAS REQUIRED TO EXPLANT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227580 PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PS10.0-50D235 9040401 00887517951168

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR