BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNACLIP BONE FIXATION SYSTEM, QUATTRO, 22MM X 16MM X 16MM

    MDR report key: 20072568 · Received August 26, 2024

    Report

    Report Number
    3007593722-2024-00008
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    UDI-DI
    M9703000112216160
    PMA / PMN Number
    D481243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE STAPLE WAS PUT OVER AN EVANS TITANIUM WEDGE TO KEEP IN PLACE AND THE LEGS ENDED UP BREAKING ON THE STAPLE CAUSING PAIN. THERE WERE TWO SIMILAR COMPLAINTS IDENTIFIED IN THE TIMEFRAME REVIEWED. ONE SIMILAR COMPLAINT WAS ATTRIBUTED TO NON-COMPLIANCE AND THE OTHER WAS ATTRIBUTED TO DESIGN. THE SIMILAR COMPLAINTS DO NOT AID IN ROOT CAUSE DETERMINATION AS THERE WAS NO REPORTED NON-COMPLIANCE, AND THE DAMAGED STAPLE IS A NEWER REVISION. THERE WERE NO ABNORMALITIES NOTED IN REGARDS TO DHR REVIEW. DHR REVIEW CONFIRMED THE STAPLE WAS RELEASED IN 2023, POST DESIGN UPDATE. PER THE IFU, THE DEVICE CAN BREAK WHEN SUBJECTED TO INCREASED LOADING ASSOCIATED WITH NONUNION OR DELAYED UNION. THE SURGICAL TECHNIQUE AND IFU DO NOT ADVICE AGAINST IMPLANTING OVER EXISTING HARDWARE. THE BROKEN DYNACLIP QUATTRO STAPLE WAS NOT RETURNED SO FULL VISUAL INSPECTION AND DIMENSIONAL INSPECTION DID NOT OCCUR. SIMULATED USE TESTING DID NOT OCCUR. THE REPORTER PROVIDED AN X-RAY OF THE BROKEN DYNACLIP QUATTRO STAPLE PRIOR TO REMOVAL. THE DISTAL LEGS OF THE STAPLE DO NOT APPEAR TO BE PROPERLY IMPLANTED INTO THE BONE, RESULTING IN THE PROXIMAL LEGS POTENTIALLY TAKING ALL THE LOADING AND FORCES. PER SR. CLINICAL SALES SPECIALIST SC, "THE MODE OF FAILURE TO THE STAPLE WAS LIKELY THE POSITIONING OF THE WEDGE. THE ANTERIOR FRAGMENT LIKELY SUBLUXED DORSALLY CAUSING MOVEMENT TO THE WEDGE AND STAPLE. THE WEDGE LIKELY PUT A MUCH HIGHER LEVEL OF STRESS ON THE LEGS WITH MOVEMENT CAUSING THE BREAK." AS THE EXPLANTED STAPLE WAS NOT RETURNED AND THE ORIGINAL IMPLANTATION POSITION REMAINS UNKNOWN, BONE OR WEDGE MOVEMENT CAN NOT BE CONFIRMED. DUE TO LIMITED INFORMATION PROVIDED, THE ROOT CAUSE SHALL REMAIN AS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STAPLE WAS PUT OVER AN EVANS TITANIUM WEDGE TO KEEP IN PLACE AND THE LEGS ENDED UP BREAKING ON THE STAPLE CAUSING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25316 DYNACLIP BONE FIXATION SYSTEM, QUATTRO, 22MM X 16MM X 16MM QUATTRO DYNACLIP STAPLE, 22X16X16 JDR MEDSHAPE, INC. 05876 M9703000112216160

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other